Position Summary

Oceaneering International Inc. Oceaneering Technologies (OII-OTECH) supports the US Navy’s submarine rescue mission through the Submarine Rescue Operations and Maintenance Contract (SROMC).

Oceaneering partners with the Navy’s Undersea Rescue Command (URC) to provide 24 / 7 world-wide submarine rescue capability to US, allied and other foreign navy requests to assist disabled submarines (DISSUB) or submersible intervention and rescue.

OII-OTECH is seeking a Senior Quality Assurance Planner who will supervise, manage and execute the provisions of the System Certification Procedures and Criteria Manual for Deep Submergence Systems.

The Quality Assurance Planner will establish and enforce submarine rescue system Quality Assurance and maintenance procedures as well as operational and safety standards.

Base pay range for this position is $35.00 to $40.00 per hour.

Duties & Responsibilities

• Implement and support a climate of first time quality in all aspects of production ensuring the highest quality final product.
• Support and instill a safety culture within the team that is in compliance with Oceaneering’s Life Safety Rules and HSE program.
• Perform ship checks and develop Controlled Work Packages (CWPs) for preventative and corrective maintenance meeting all requirements of NAVSEA SS800-AG-MAN-010 / P9290 System Certification Procedures and Criteria Manual for Deep Submergence Systems, the OTECH Quality Management System Manual (ISO-T-00001), and other higher level authority guidance.
• Assist in coordinating work outages to include scheduling / sequencing work and developing test plans.
• Research and develop Job Materials List for all preventative and corrective maintenance items.
• Maintain Deep Submergence Systems Scope of Certification (DSS-SOC) requirements (processes and personnel) in accordance with the Systems Certification Procedures and Criteria Manual for Deep Submergence Systems.
• Assist in the establishment and maintenance of certification in accordance with NAVSEAINST 4855.34B as recognized and reflected in NAVSEA Notice 5000.
• Assist in the development and maintenance of a Quality Assurance Program that meets the requirements of ANSI / ISO / ASQ Q9001-2015 or equivalent.

Support ISO audits as directed by the OTECH Quality Manager.

Use Re-Entry Control (REC) procedures / processes and develop / obtain required Objective Quality Evidence (OQE) for maintenance within DSS-SOC boundaries and work performed that validates adherence to the applicable requirements of NAVSEA SS800-AG-MAN-010 / P9290 (Systems Certification Procedures and Criteria Manual for Deep Submergence Systems),and NAVSEA SS521-AA-MAN-010 (U.

S. Navy Diving and Manned Hyperbaric System Safety Certification Manual), and SROMC SFX-T-00007 SRDRS Quality Maintenance Manual.

Support regular reviews which include functional audits, sustaining surveys, and quality assurance surveillances as directed and scheduled by the government.

Quickly and efficiently determine root cause(s) and take short and long-term corrective actions to resolve any certification or non-compliance deficiencies noted during any review.

• Oversee the development and use of formal work packages in accordance with appropriate industry standards and best commercial practices for non-DSS-SOC and non-Rescue Critical Item maintenance for Rescue Critical Items (RCI).
• Assist in the implementation of a Quality Management and Assurance program which includes a training, qualification, and tracking process for personnel.
• Assist in the maintenance of a Quality Assurance Program internal audit and surveillance program, IAW the OTECH Quality Management System Manual (ISO-T-00001) to monitor work performance and compliance with the contract.

requirements and to determine the effectiveness of the quality program. The program shall emphasize assurance of quality through controlled, disciplined, well-defined work processes.

• Provide administrative and technical support services to the Sustaining Activity URC during scheduled Rescue Systems Certification Sustaining Surveys.
• Review Objective Quality Evidence (OQE) documentation.
• Communicate with engineering yard to correct and seek resolution regarding technical deficiencies.
• Support the government Quality Assessment Surveillance Plan (QASP).
• Provide administrative and technical support services to the CO URC during quality assurance audits / surveillances.
• Support quality initiatives such as process and product characterizations that lead to continuous / cost improvements
• Conduct benchmarking to develop more effective methods for improving quality.
• Lead and / or provide support to continuous improvement initiatives and training on continuous improvement, as requested, by other functional departments.
• Identify, measure, analyze, and report the Cost of Poor Quality (COPQ). Make recommendations to senior leadership on corrective actions required to reduce COPQ.
• Collect data and execute / conduct various analytical / statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop test procedures.
• Attend various meetings and action / communicate status or instructions.
• In-process inspecting and testing in accordance with Quality System work instructions. Included in this are reading drawings / blueprints, determining methods for dimensional inspections, inspection of paint and other coatings, weld inspection, and identification of material and inspected items to show inspection status.
• Final inspection to verify that items exhibit acceptable workmanship, and inspection reports / certificate of conformance are ready for shipment with the product.
• Conduct periodic training of planners, inspectors, and new hires.
• Maintain logs; fill out nonconforming material reports and other required records of inspection and tests.
• Assure that inspection gages and equipment are in current calibration.

Qualifications

• High school diploma or equivalent.
• Minimum 3 years of Quality Assurance and / or DSS-SOC experience.
• Ability to manage multiple projects simultaneously with superior attention to detail.
• Leads / participates in cross-functional teams.
• Extensive travel and an ability to work away from home for periods up to 45 days.
• Skillset to effectively present information and respond to questions.
• Must be able to perform well both autonomously and in working with teams.
• Comprehensive knowledge of quality management systems and principles and a variety of operational excellence processes.
• Ability to communicate effectively with all levels of employees, suppliers, customers, and regulatory agencies.
• Practical experience in problem solving and root cause analysis methods.
• U.S. Citizenship is required.
• A current SECRET clearance or the ability to obtain a SECRET clearance.

Summary

Posted : Jun 13, 2023Weekly Hours : 40 Role Number : 200485066 Would you like to build and seamlessly integrate technologies that enrich people’s lives and deliver the best user experience?

At Apple, new ideas have a way of becoming extraordinary products, services, and customer experiences very quickly. Bring passion, dedication, and a commitment to quality to your job, and there's no telling what you could accomplish! We are the Product System Quality team, and we are looking for an experienced and highly motivated Software Quality Assurance Engineer.

You will join a dedicated and dynamic team of people that focus on creating a magical experience with AirTag, Digital Car Key, and iOS devices for our customers.

Your role is to make sure that our customer experience is amazing. You will be collaborating with many different teams within Apple to further improve the quality of our products, and keep a mindful eye on how we can make them even greater. Come join our team!

Key Qualifications

• Committed to quality and passionate about customer experience
• Possess a deep understanding of SQA methodologies & practices
• Strong working knowledge of USB, NFC, UWB, 802.11 WLAN / WiFi, and Bluetooth standards
• Experience testing wireless functional, performance, co-existence, and stability testing
• Scripting experience in Shell, Python, or equivalent
• Ability to work independently and thrive in fast-paced environments
• Highly organized, creative, self-motivated, and passionate about achieving results
• Excellent written and verbal communication skills and experience presenting data to cross-functional teams and / or management

Description

• Work within and outside of our team to develop and implement a rock-solid test plan.- Identify fundamental metrics to track the project and team’s success - Collaborate with development and QA teams working on this project to ensure requirements are understood, achievable, and tested.
• Investigate and debug difficult problems, and help drive them to closure. - Be a vocal proponent for quality in every phase of the development process.

Education & Experience

Bachelors or Masters in Computer Science, Computer Engineering, Electrical Engineering

Additional Requirements

Pay & Benefits

At Apple, base pay is one part of our total compensation package and is determined within a range. This provides the opportunity to progress as you grow and develop within a role.

The base pay range for this role is between $113,500 and $207,000, and your base pay will depend on your skills, qualifications, experience, and location.

Apple employees also have the opportunity to become an Apple shareholder through participation in Apple’s discretionary employee stock programs.

Apple employees are eligible for discretionary restricted stock unit awards, and can purchase Apple stock at a discount if voluntarily participating in Apple’s Employee Stock Purchase Plan.

You’ll also receive benefits including : Comprehensive medical and dental coverage, retirement benefits, a range of discounted products and free services, and for formal education related to advancing your career at Apple, reimbursement for certain educational expenses including tuition.

Additionally, this role might be eligible for discretionary bonuses or commission payments as well as relocation. about Apple Benefits.

Note : Apple benefit, compensation and employee stock programs are subject to eligibility requirements and other terms of the applicable plan or program.

JOB DESCRIPTION

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.

We are more than 6, strong and do business in over countries, providing answers with fast, accurate and consistent testing where and when they are needed most home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.

Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Senior Quality Assurance Engineer. The purpose of this position is to professionally interact and participate in the design and execution of all quality related deliverables per Quidel Quality Management System to support new product development.

Drive product / process improvements through leading / assisting Corrective Action / Preventive Action activity. Provide direction and training to team members for Risk Management and other cross functional Quality type procedures and processes to support new product development.

Carries out other duties as assigned in compliance with established business policies.

This position will be located onsite in San Diego, CA

The Responsibilities

Responsibilities include supporting new product design / development activities utilizing internal and external quality derived industry standards.

The incumbent may also lead corrective action / preventive action projects.

Administering Master Validation Plans (MVP)

Develop Risk Management File

Develop new product design trees

Generate Change Orders as required to support New Product Development and / or corrective / preventive action projects.

Monitor Development Trace Matrix requirements

Determine experimental sampling plans

Assist in transitioning product from development to manufacturing

Develop qualification test plans for new raw materials, injection molded parts and manufacturing equipment

Assist in development of raw material, production material and product specifications

Summarize experimental data and draw conclusions.

Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process.

Active participation with corrective action / preventive action projects in accordance with Quidel’s Quality Management System.

Assist in maintaining the Quality Management System

Maintain a safe working environment.

The Individual

Required Skills :

Must have experience as a Quality Engineer : 5+ years

Must have experience as a Quality Engineer on new product development : 3+ years

Must have experience working and managing time lines / deliverables. BA / BS in Scientific field required, QE certification desired.

New product development design control processes

Project planning

Strong analytical and problem solving skills

Good organizational skills, and the ability to manage multiple tasks

Experience in experimental design

Ability to work within cross functional teams

Strong communication skills, written and verbal

Must exhibit professionalism, confidence, maturity, desire to succeed and be proactive / self-motivated

Strong knowledge of relevant Quality and analytical tools

Ability to participate in planning and managing project deliverables

Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts, Risk Management, Quality Test Plans and Master validation plans)

Knowledge of related quality systems regulations and processes

Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)

The Key Working Relationships

Internal : R&D, Engineering, Quality, Operations and Regulatory, Supplier Quality Engineers, Process Engineers and Manufacturing Quality Engineers

External : Vendors and contractors

The Work Environment

The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines.

Occasional travel required. Travel includes airplane, automobile travel and overnight hotel.

Essential functions are subject to change as other duties may be assigned.

Position requires ability to lift up to 30 lbs. on a regular basis. Typically 40% of time in meetings (attend ADHOC meetings is essential to this position);

60% of time at the desk on computer / doing paperwork / on phone, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role.

Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must be able to visually monitor products for Quality Standards.

Position may be required to use Personal Protective Equipment as posted.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data.

At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case.

The salary range for this position is $78,.00 - ,.00. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a (k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.

All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

LI-AH1

The Opportunity

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine.

We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked.

Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow as QuidelOrtho, we are seeking a Senior Quality Assurance Engineer. The purpose of this position is to professionally interact and participate in the design and execution of all quality related deliverables per Quidel Quality Management System to support new product development.

Drive product / process improvements through leading / assisting Corrective Action / Preventive Action activity. Provide direction and training to team members for Risk Management and other cross functional Quality type procedures and processes to support new product development.

Carries out other duties as assigned in compliance with established business policies.

This position will be located onsite in San Diego, CA

The Responsibilities

Responsibilities include supporting new product design / development activities utilizing internal and external quality derived industry standards.

The incumbent may also lead corrective action / preventive action projects.

Administering Master Validation Plans (MVP)

Develop Risk Management File

Develop new product design trees

Generate Change Orders as required to support New Product Development and / or corrective / preventive action projects.

Monitor Development Trace Matrix requirements

Determine experimental sampling plans

Assist in transitioning product from development to manufacturing

Develop qualification test plans for new raw materials, injection molded parts and manufacturing equipment

Assist in development of raw material, production material and product specifications

Summarize experimental data and draw conclusions.

Maintain project documentation in accordance with internal Quidel and external regulatory requirements as part of the design control process.

Active participation with corrective action / preventive action projects in accordance with Quidel’s Quality Management System.

Assist in maintaining the Quality Management System

Maintain a safe working environment.

The Individual

Required Skills :

Must have experience as a Quality Engineer : 5+ years

Must have experience as a Quality Engineer on new product development : 3+ years

Must have experience working and managing time lines / deliverables. BA / BS in Scientific field required, QE certification desired.

New product development design control processes

Project planning

Strong analytical and problem solving skills

Good organizational skills, and the ability to manage multiple tasks

Experience in experimental design

Ability to work within cross functional teams

Strong communication skills, written and verbal

Must exhibit professionalism, confidence, maturity, desire to succeed and be proactive / self-motivated

Strong knowledge of relevant Quality and analytical tools

Ability to participate in planning and managing project deliverables

Working knowledge of manufacturing tools and processes (i.e. BOM, Routings, SPC Charts, Risk Management, Quality Test Plans and Master validation plans)

Knowledge of related quality systems regulations and processes

Appropriate computer skills (e-mail, word processing, statistical, spreadsheet and graphing software)

The Key Working Relationships

Internal : R&D, Engineering, Quality, Operations and Regulatory, Supplier Quality Engineers, Process Engineers and Manufacturing Quality Engineers

External : Vendors and contractors

The Work Environment

The work environment characteristics are representative of both an office and manufacturing environment. Flexible work hours to meet project deadlines.

Occasional travel required. Travel includes airplane, automobile travel and overnight hotel.

Essential functions are subject to change as other duties may be assigned.

Position requires ability to lift up to 30 lbs. on a regular basis. Typically 40% of time in meetings (attend ADHOC meetings is essential to this position);

60% of time at the desk on computer / doing paperwork / on phone, doing analytical work. Walking, standing, and sitting for long periods of time are routine to accomplish tasks in this role.

Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Must be able to visually monitor products for Quality Standards.

Position may be required to use Personal Protective Equipment as posted.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data.

At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case.

The salary range for this position is $78,600.00 - 145,000.00. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays.

All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Essential Job Functions :

• Have software quality and quality systems compliance responsibilities for Medical Device Systems Firmware and Medical Device Mobile Applications for Class C Software.
• Providing technical leadership and software quality engineering support on Medical Device Firmware and Software for Medical Mobile Apps related projects.
• Providing software quality support and drive validation strategies.
• Supporting risk management activities to support software product(s).
• Managing software defects and problem reports.
• Develop and implement comprehensive software quality assurance strategies, policies, and procedures that ensure compliance with applicable regulations and standards in the medical device industry.
• Collaborate with cross-functional teams, including manufacturing, engineering, regulatory affairs, and clinical operations, to identify and address quality-related issues and drive continuous improvement.
• Review Software Specifications / Requirements documents, Review and approve Software Verification Test Plans, Verification Test Cases, Verification / Validation protocols, Trace Matrices and Verification / Validation Summary Reports for Software Testing.
• Ensure high quality software releases.
• Support non-product software tool validation assessment, requirements, and verification testing as needed.
• Lead continuous improvement projects for software device development, production, and quality processes.
• Ensure that software device quality and regulatory standards are met, including meeting FDA Part 820, ISO 13485, IEC 62304, MDR, and MDSAP requirements as applicable.
• Assist in developing and maintaining post market activities related to software, i.e. complaint handling, cybersecurity testing, software related quality metric monitoring, etc.

Experience and Qualifications :

Education :

Bachelor's or Master's degree in engineering, science, or a related field.

Experience :

• Minimum of 5 years of experience in a software quality assurance management role in the medical device industry.
• Proven track record of successful management of quality teams and implementing quality management systems in accordance with applicable regulations and standards.
• In-depth knowledge of FDA regulations (e.g., 21 CFR Part 820), ISO standards (e.g., ISO 13485), IEC 62304 and other applicable regulations and standards.
• Experience leading software quality initiatives in collaboration with the product development teams and ensuring that products meet or exceed quality standards and customer expectations.
• Must be technically strong and have experience testing mobile applications and medical device firmware.
• Experience supporting FDA, Notified Body, and other regulatory submissions and inspections.

Preferred Skills :

• Software Quality Engineer Certification (CSQE) from ASQ or equivalent
• Knowledge of FDA’s Cybersecurity Requirements, Testing, and Expectations

PI223225917