Company : KARL STORZ Endoscopy-America, Inc. (KSEA)

Job Code : 13465

Pay Grade : US-D18

Salary Range : $95,000 - $151,500

Description

KARL STORZ SE & Co. KG based in Tuttlingen, Germany, is a family-owned, global company committed to benefiting humanity by advancing medical technology through innovation and education.

For more than 75 years, KARL STORZ has been dedicated to earning its international reputation as a leader that designs, engineers, manufactures, and markets all its products with an emphasis on visionary design, precision craftsmanship, and clinical effectiveness.

KARL STORZ is currently searching for a Regulatory Intelligence Manager who will assure that all information for a worldwide approval or registration for the assigned products and projects is available.

This position will be responsible for ensuring state-of-the-art requirements, defined by regulatory bodies, are included in the new product development or product change for the assigned products;

ensuring all global approvals and conformity assessment processes meet current regulatory requirements (support enhancements / updates as required) and assist in meeting all Regulatory compliance objectives.

Responsibilities

• Prepare products for regulatory release.
• Identify, analyze, interpret, and communicate relevant global regulations and technical standards that apply to the assigned products and projects , including compilation of information from :

Global Regulatory Assessments

• Published regulations and standards (e.g., FDA, MDR, RoHS, ISO, EN, IEC, ASTM)
• Published guidance documents
• Draft regulations and standards
• Regulatory and certification agency interpretations
• KARL STORZ policies and procedures
• Ensure new products meet requirements of applicable regulations and standards (State of the Art). Work with product development teams from product conception through development and during entire product lifecycle to accomplish the following :

Identify applicable standards, including electrical safety, EMC, sterility assurance, material compatibility, software, etc.

• Ensure inclusion of specific regulatory and standard requirements in product specifications
• Analyze proposed solutions and / or required components and construction
• Collaborate with the risk management team; assess risks, review mitigation measures, evaluate residual risks.

Perform subsequent audit of risk mitigation measures.

• Review test plans and design verification / validation reports
• Ensure adherence to labeling requirements as dictated by global regulatory agencies and KARL STORZ requirements (product, Instruction manual / card, shipping box, etc.)
• Perform Phase Gate Reviews (Design History File reviews) and product release
• Coordinate document submissions to KSEA and KST Regulatory departments for :

US 510k & PMA submissions

• EU Technical File compilation and CE Marking
• Other international registrations and approvals
• Assure the assigned products meet the certifications requirements to relevant standards.

Support. Provide medical electrical equipment safety (IEC60601-1) and medical electrical equipment electromagnetic compatibility (IEC60601-1-2) when applicable

Ensure appropriate controls for Engineering Change process, including :

Change control for PMA devices and / or 510k devices

• Safety agency review / approval for changes to safety critical components
• Liaison to Regulatory Affairs Material compliance group for RoHS compliance of changes to components and finished products
• Provide audit support as needed for quality systems audits (TUV, FDA, Inter-Corporate, etc.). Support resolution of internal / external audit findings related to Regulatory Compliance.
• Participate in investigation and resolution of customer complaints and CAPAs, as needed.
• Participate as a member of continuous improvement projects / teams seeking ways to improve the quality of KSE's products and services.
• Participate and influence US National Standards Committees as requested in coordination with Corporate Regulatory Compliance.
• Perform other related duties as assigned by supervisor
• Regular attendance is an essential job function

Requirements

• Bachelor's degree in Engineering or related technical field with 7+ years' experience in medical device regulatory compliance or Master's degree in Engineering or related technical field with 5+ years of experience in medical device regulatory compliance.
• Knowledge and experience working with electro-mechanical software driven medical devices.
• Knowledge of EU Directives, particularly; MDR, Machinery Directive, EMC Directive and Low Voltage Directive.
• Familiarity with Medical Device Compliance guidance / standards - EMC ( e.g. IEC / EN 60601-1-2) and Electrical safety (e.

g. IEC / EN 60601-2-18), Software (e.g. IEC / EN 62304), Biocompatibility (e.g. EN / ISO 10993 series), Sterilization (e.

g. EN / ISO 113X), Labeling (e.g. EN / ISO 15223), etc.

• Knowledge of medical device quality system regulations and standards (e.g. EN / ISO 13485, FDA QSR, MDSAP, etc),
• Understanding the application of Risk Management principles (e.g. EN / ISO 14971)
• Excellent written and oral communication skills.
• Results oriented, and ability to manage multiple projects simultaneously
• Proven ability with Word Processing, Excel, Visio and other Microsoft Office applications
• Ability to travel to other KS sites globally (10-20%)

Preferences

• Experience with SAP preferred.
• Experience in Project Management preferred.
• Experience in KARL STORZ structures and business acumen preferred

LI-CW1

Pay Transparency

The salary range and / or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future.

When determining a specific team member's base salary and / or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.

Vaccine requirements at KARL STORZ due to COVID-19

KARL STORZ is committed to maintaining a safe work environment for our employees and therefore we require the COVID-19 vaccine for all of our employees unless otherwise due to an underlying medical condition or sincerely held religious beliefs.

During the interview process, we encourage you to ask how COVID-19 may impact the role you are seeking and if you require a reasonable accommodation regarding the vaccine requirement see below for the process for requesting accommodation.

Please click here to learn more about our overall response to COVID-19.

Employee Benefits Program Overview for U.S. Locations

• Medical / Dental / Vision including a state-of-the-art wellness program and pet insurance, too!*
• 3 weeks vacation, 10 holidays plus paid sick time*
• Up to 8 weeks of 100% paid company parental leave
• 401K retirement savings plan providing a match of 60% of the employee's first 6% contribution
• Section 125 Flexible Spending Accounts
• Life, STD, LTD & LTC Insurance
• We prepay your tuition up to $5,200 per year! - Tuition preimbursement
• Fitness reimbursement of up to $200 annually
• Employee referral program of up to $2,000 per hire
• And much more!
• Field sales, internships, and part-time employees are not eligible except where required by state law.

Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.

To include, maternal / paternal leave, adoption, and fostering of a child.

KARL STORZ reserves the right to change or modify the employee's job description whether orally or in writing, at any time during the employment relationship.

Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor.

Employee must comply will all applicable KARL STORZ policies and procedures.

Equal Employment Opportunity & Reasonable Accommodation Statement

KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences.

To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status or any other protected characteristic.

KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at [email protected]

Notice to Employment Agencies

This recruitment assignment is being managed directly by KARL STORZ's Human Resources team. Human Resources will reach out to our preferred, contracted agency partners in the rare instance additional talent options are required.

Your respect for this process is appreciated. KARL STORZ does not accept unsolicited Agency resumes. Resumes received which were unsolicited by the KARL STORZ Human Resources department will be ineligible for referral fees.

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At Chevron Stations Inc (CSI), we sell gasoline and convenience products at our retail stations. We are looking for hard working people who value safety, enjoy working as a team and have a positive work attitude.

The perfect fit for our team are individuals who are self-motivated, dependable and able to work effectively & safely in a fast-paced environment while maintaining 100% total customer focus.

Job Expectations :

Assist Station Manager in the day-to-day operations of the retail facility.

Maintain oversight of station operations and staff in the Station Manager’s absence.

Provide work direction, motivation and coaching to staff during shifts to ensure assigned tasks are completed in accordance with CSI’s guidelines and expectations.

Support and adhere to execution of established safety, security, quality guidelines, as well as all other CSI policies, procedures, practices, and programs.

Respond to accidents or incidents in a professional and timely manner, including escalating to Station Manager or Business Consultant as appropriate.

Understand the importance of and ensure all station employees comply with company wage & hour requirements.

Support and adhere to CSI’s cash / money handling and accountability processes.

Preserve safety of self, fellow employees, and all others in the work location by utilizing the CSI Loss Prevention process.

Role-model safe behaviors.

Maintain courteous, professional contact with co-workers, customers, vendors and community at large.

Reliable and predictable attendance.

Perform all duties of Customer Service Representative (CSR) as needed.

Principal duties include but are not limited to :

Store Operations

Provide work direction to staff during shifts to ensure station operations are covered including, but not limited to customer service, stocking, cleaning, and food-service.

Assist with product inventory management. This includes but is not limited to :

Coordinate with other stations to limit out-of-stocks in station across the zone.

Follow CSI guidance to ensure correct volume and products in stores. Conduct mini-audits, as requested, to ensure accurate stock levels.

Support and adhere to CSI’s cash / money handling and accountability processes; comply with Loss Prevention processes; effectively utilize all transactional equipment (cash registers, electronic safe, lottery, fuel, phone card, EBT, and credit card, etc.

to efficiently process customer transactions. Provide assistance / training to CSRs as needed.

Use, operate, clean, and maintain cleanliness of all food service equipment (coffee, fountain drink machine, frozen beverages, iced tea, hot dog grille, microwave, etc.

Provide assistance to CSRs as needed

Inform Station Manager of any issues or concerns that might affect the store’s customer service, safety record, profitability, or adherence to any Company’s Policies and Procedures.

Ensure self, station personnel and contractors on shift comply with CSI’s safety standards; use appropriate personal protective equipment as required.

Use various computer programs to support daily operations of the store. Complete daily / weekly administrative tasks regarding retail & gas sales, compliance, daily paperwork, deliveries, invoice processing, etc.

In the absence of Station Manager, keep Business Consultant informed of station operations and issues.

Perform job duties of a CSR and other duties as needed or assigned by Station Manager or Business Consultant.

People Management

Understand the importance of and ensure all station employees understand and comply with the company wage & hour guidelines.

Support and role-model CSI’s core values of safety, diversity, inclusion, integrity and trust.

Job Specifications

Skills and experience include but are not limited to :

Required :

Previous experience in a fast-paced retail, food service or fuel environment, including cash handling and customer service experience.

Demonstrated experience operating a cash register, computer console, and other related equipment, tools and computer software programs & applications.

Knowledge and application of proper sanitation and safety requirements associated with food storage and serving.

Available to work a variety of hours, which may include early mornings, evenings, weekends, overnight shifts, and holidays, based on business needs.

Ability to multi-task in fast-paced environment.

Ability to handle challenging situations professionally, exercising good judgement.

Ability to work both independently and in team settings.

Strong interpersonal and verbal & written communication skills.

High School graduate or equivalent and a minimum 21 years of age.

Travel

Rare, limited to required training, zone / district training or coverage for nearby stations.

Physical demands include but are not limited to :

Perform the following continuously throughout the shift : walking and standing, sometimes on hard and uneven surfaces, reaching, grasping and pushing buttons.

Perform the following frequently throughout the shift : bending, stooping, pushing, pulling, reaching below waist.

Continuously lift weights up to 10lbs; occasionally lift weights up to 35lbs. Follow the team-lift concept if objects are too heavy or awkward.

Work safely with equipment that can create and hold very high temperatures while always using appropriate personal protective equipment.

Periodic exposure to all outdoor conditions.

Periodic exposure to cleaning supplies and chemicals, salt, spill absorbents, etc.

Occasional exposure to walk-in coolers at 34 F.

Must be at least 18 years of age or older to work in California and Oregon locations.

Must be at least 21 years of age or older to work in Washington locations.

Must be at least 21 years of age or older to work Graveyard shift from 10pm to 6am.

Must be at least 21 years of age or older to work in Management positions.

• Please note that the compensation and benefits listed below are only applicable for U.S. payroll offers.
• The selected candidate’s compensation will be determined based on their skills, experience, and qualifications. The compensation and reference to benefits for this role is listed on this posting in compliance with applicable law.

USA based job position

Visas will not be granted

Benefits :

• Full-time & Part-time shifts available
• Direct Deposit with competitive weekly pay
• Health & Wellness packages available for purchase
• Education reimbursement program
• Shift Differential Pay for select shifts and job titles
• Management Bonus Program
• Loyalty Service time Program
• Commuter benefit Program

Compensation Range : $17.52 - $26.28

$17.52 - $26.28

Chevron Stations Inc. (CSI) is an Equal Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, color, religious creed, sex (including pregnancy, childbirth, breast-feeding and related medical conditions), sexual orientation, gender identity, gender expression, national origin or ancestry, age, mental or physical disability (including medical condition), military or veteran status, political preference, marital status, citizenship, genetic information or other status protected by law or regulation.

We are committed to providing reasonable accommodations for qualified individuals with disabilities. If you need assistance or an accommodation, please email us at [email protected]

Chevron Stations Inc. (CSI) is an Equal Opportunity / Affirmative Action employer. Qualified applicants will receive consideration for employment without regard to race, color, religious creed, sex (including pregnancy, childbirth, breast-feeding and related medical conditions), sexual orientation, gender identity, gender expression, national origin or ancestry, age, mental or physical disability (including medical condition), military or veteran status, political preference, marital status, citizenship, genetic information or other status protected by law or regulation.

We are committed to providing reasonable accommodations for qualified individuals with disabilities. If you need assistance or an accommodation, please email us at [email protected]

Job Description

FLINT is growing and is looking for Turnaround / Shutdown Managers instrumental to securing bids for turnaround / shutdown work and construction projects awarded and upcoming.

Successful candidates will have a keen eye for safety, quality, and schedule, with proven experience as an engaging and motivational leader.

Opportunities are available across Western Canada, with most of our work in Alberta and Northeastern British Columbia. Contract lengths are dependent on each project.

Successful applicants must be able to travel or relocate for the project’s duration.

Perks of the job

• Competitive compensation package dependent on your experience and the complexity of the Turnaround / Shutdown.
• The opportunity to engage in a range of exciting projects, keeping your work experience fresh and challenging.
• Variety in your work that allows you to develop a diverse skillset, making you more adaptable and marketable in your career.
• Potential for long-term opportunities on multiple projects to provide stability and the potential for growth within the organization, making it a rewarding choice for your professional journey.
• Enhance your leadership and communication skills with the opportunity to lead and collaborate with various professionals within the organization.
• Work with a variety of best-in-class clients.

What would you be doing?

• Provide leadership and guidance to the turnaround team during the planning, execution, and closure phases.
• Facilitate developing, communicating and achieving the turnaround goals and objectives.
• Implement Standardize Turnaround processes and procedures to foster continuous improvement.
• Develop and maintain a Milestone & Activity Chart to identify required activities to organize, plan and execute the turnaround.
• Develop an integrated execution plan which includes work scope, capital and engineering projects.
• Monitor the project’s overall status to address significant deviations and implement mitigation strategies.
• Ensure safety and quality are maintained by Turnaround Team members, employees, and contractors.
• Implement a logistics plan to ensure smooth execution and efficient demobilization of resources and equipment.
• Ensure all post-turnaround work scope is prioritized and completed on time.
• Develop turnaround lessons learned and evaluate the performance of all contractors and vendors.

Does this sound like you?

• Significant experience using SAP, Primavera, and standard Microsoft Office Software
• Strong leadership skills with the ability to lead by example.
• High degree of mechanical aptitude.
• Ability to read and understand complex instructions.
• Displays a safe and productive work ethic.
• Handle the administrative duties of the position, including completion of required documents.
• Read and interpret drawings.
• Journeyman ticket in a mechanical trade or degree in a mechanical discipline.

Other important details

These positions have been identified as a safety sensitive position and will require completion of a drug and alcohol testing.

Why FLINT

FLINT strives every day to be recognized as your employer of choice, modelling our core values not only to our customers but also to our employees.

We promise to uphold these values by providing a safe, progressive, and proactive work environment while continuously working to minimize our impact on our planet.

We will work daily to build our employees into leaders, fostering a work environment of integrity, curiosity, empowerment, and innovation.

At FLINT, we recognize that our greatest resource is our people. Combining world-class workforce solutions with top-tier talent, together will build upon our reputation of unwavering quality, safety, and customer satisfaction.

We are committed to creating a culture of equity, diversity, and inclusion, including fostering a safe and respectful environment that allows for diverse perspectives a work environment in which all employees are valued and have an equal opportunity to achieve success.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability, protected veteran status, or other legally protected factors.

Description : JOB SUMMARY

JOB SUMMARY

Manages the daily operations of the medical practice including personnel, financial, clerical, housekeeping, and maintenance and purchasing functions.

Plans programs, allocates, and assigns duties to employees. Reviews medical records for compliance and billing requirements.

Monitors activities and operations to ensure that the practice successfully meets its objectives.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Personnel :

• Leads Employees to accomplish all job objectives in line with clinic mission and vision
• Conducts one on one meetings with clinic leads to coach, mentor and to help them to establish and implement goals, objectives
• Responsible for maintaining high moral and good relations throughout the office.
• Schedules and conducts periodic office staff meetings to inform the staff of changes in the practice's policy, to update and educate staff, and to resolve and prevent problems;

prepares and retains minutes of all meetings.

• Consults with Human Resources or Administration prior to a formal counseling or dismissal of employee(s).
• Processes all paperwork in a timely manner and forwards to appropriate departments (i.e., Administration, Payroll etc.), for time off, counseling actions, and performance evaluations.
• Works with Quality Improvement Department to conducts periodic Quality Improvement activities and shares data with staff
• Conduct performance reviews. Recommends staff merit increases, promotions and disciplinary actions.
• Completes and updates personnel files-ensures required forms are completed.
• Submits office staff time cards for payroll processing bimonthly-verifies accuracy and completeness of employee time.
• Approve and maintains all vacation and other days off schedules for providers and staff.
• Ensures all positions are filled with trained personnel during vacation / sick calls and fill in when needed.

Daily Operations :

• Conducts monthly audits to ensure compliance with policies and procedures
• Manages and reviews providers' schedule and review bins
• Works closely with the provider and Medical Director to ensure clinical and administrative goals are met
• Assists Medical Director to keep track of providers time off and to ensures coverage for patient care
• Ensures office is opened and closed daily, according to protocol.
• Oversees and distributes work activities and schedules.
• Assists in the development of clinic budget
• Maintains compliance with budget and productivity goals
• Attends monthly Operations and Leadership Meetings
• Directs operations to prepare and retain records, files, reports and correspondence according to various government and practice standards, prepares and carries out managed care audit requirements.
• Ensures consistent collection of payment at time of service.
• Oversees all handling of daily collections and prepares for transfer to accounting department.
• Manages and reconciles the petty cash
• Ensures sufficient supplies available for delivery of quality patient care orders supplies as needed and obtains competitive bids at least annually.
• Initially sorts the daily mail and distributes appropriately.
• Monitors the duties assigned to practice personnel to ensure that employees are performing their assignments maintaining a high level of patient care and job efficiency.
• Performs other duties as directed by administrator and / or medical director to achieve desired results
• Creates dashboards for presentation and calls out issues and provides recommendations
• To advise provider(s) / staff in areas of practice and business management, to maximize patient care and service, and to direct efficient and profitable operations of the practice.
• Takes accountability for revenue generated (Profit & Loss) for the office and the group as an entity as a whole.
• Performs other duties.

Requirements :

EDUCATION, TRAINING AND EXPERIENCE

• High School Diploma or GED required.
• Graduation from junior college or an accredited University is a plus.
• Minimum of three to five years of work experience, with increased responsibility, in a medical environment.
• Minimum of one year of experience supervising staff.

PAY RATE : $64,480-80k annually

BENEFITS :

Medical, Dental and Vision 100% paid by Employer

Life Insurance and Accidental Dismemberment 100% paid by Employer

Paid Holidays

Paid Time Off

401K

401K Matching

Flexible Spending Account

Fringe

Supplemental Insurance

PI223771308

Job Summary

Free movies, free popcorn, flex schedules and more! Supervise and coordinate operations of the theatre to achieve AMC’s goals.

Provide leadership and development, and communicate expectations to all associates in a professional and safe work environment.

Benefit Summary

Build strong communication, leadership, and time management skills at AMC, and take advantage of our opportunities for career advancement.

AMC team members enjoy a very competitive benefits package including, accrued vacation / absentee time, medical / dental / vision coverage, 401(k) match, free popcorn daily, half off eats and drinks at the theatre, and most importantly for us movie people FREE movies!

AMC’s company culture is focused on innovation and diversity to ensure that we provide the latest and greatest experience for our guests and associates.

We lead by example in doing what is right and take responsibility for our own results and our company’s success.

Job Description

PREFERRED QUALIFICATIONS

• One year experience in guest-focused business (e.g. retail, restaurant, hospitality, etc.).
• Working knowledge of all theatre crew functions.
• Strong oral and written communication skills.
• Proficiency in MS Suite.

ESSENTIAL FUNCTIONS

• Lead and develop theatre crew and supervisors to perform the essential functions of their positions.
• Provide direct supervision and guidance to crew members.
• Ensure that associates satisfy all AMC guest service standards.
• Ensure proper staffing in each area.
• Perform daily, opening, and closing operational and administrative duties.
• Reinforce guest and operational focus through MBWA (Managing By Walking Around).
• Review financial numbers to optimize financial results and the guest experience.
• Take ownership of the successful completion of personal training program.
• Oversee an individual theatre department as assigned, if applicable.
• Assist with hiring, training, developing, and appropriately disciplining associates.
• Work effectively with supervisors, peers, subordinates, guests, vendors, and corporate partners.
• Listen, communicate, and work effectively with guests in high-volume setting.
• Ability to work and meet deadlines with minimal supervision.
• Maintain regular personal attendance for all scheduled shifts per the Management Work Schedule Policy.
• Uphold AMC’s business practice standards and ensure compliance with company programs and policies.
• Complete all other functions and assignments as assigned by the General Manager / Senior Manager (where applicable).
• Assist the General Manager / Senior Manager with achieving guest service and financial goals associated with Food and Beverage.
• Oversee and complete theatre administrative reports.

UNIFORM

• Provided by theatre : AMC-issued shirt, black pants, black belt, nametag.
• Provided by associate : Black shoes, socks.

AMC and its subsidiaries are committed to equal employment opportunity and complies with all applicable federal, state, and local employment laws.

AMC strictly prohibits and does not tolerate discrimination and will provide equal employment opportunities to all applicants without regard to an applicant’s race, color, religion, creed, gender, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, disability, military status, veteran status, genetic information, or any other reason prohibited by applicable federal, state, or local law, regulation, or ordinance.

This policy applies to all terms and conditions of employment, including, but not limited to, hiring, promotion, discipline, compensation, benefits, and termination of employment.

Compensation Information

AMC provides a compensation range for open positions where required. Factors that may be used to determine actual compensation may include, but are not limited to, specific skill-set, relevant experience or geographic location.

The compensation range for this position may be lower or higher in different markets based on business needs.

The compensation for this position is : $22.10 to $23.20

Minimum Job Requirements

• Age 18 or older. Other location-specific age requirements may apply.
• Six months supervisory or commensurate leadership experience.

Requirements to be performed, with or without reasonable accommodation :

• Standing, walking, lifting, twisting, and bending on a frequent basis.
• Ability to lift up to 50 pounds and carry it up to 90 feet (or deposit into dumpster or trash compactor).

About AMC

AMC amazing. That’s the promise we deliver to nearly 35,000 associates, 240 million guests domestically, and 350 million guests worldwide each year.

AMC has propelled industry innovation since 1920, and we continue to innovate by delivering premium sight and sound, new and improved food and beverage options, and diverse content in our state-of-the-art theatres.

We focus on delivering friendly, superior service to our guests. We lead by example, have fun, and give back to the communities in which we live and work.

If you feel motivated and energized by our culture, and if you can name your three favorite movies in the next 30 seconds, then AMC may be the right place for you.

We offer competitive compensation, excellent benefits, and an environment that encourages teamwork, inclusion, collaboration, and results.

Address

189 The Grove Drive

Location Address

189 The Grove Drive, Los Angeles, CA 90036

City

Los Angeles

State

California

Zip Code

90036

Employment Status

Full Time

Pay Rate Type

Hourly

Job ID

25548BR