Position : Quality Assurance Associate / Junior Quality Assurance Specialist

Job Summary :

The Quality Assurance Associate / Junior Quality Assurance Specialist is responsible for supporting the implementation and maintenance of quality systems and ensuring compliance with regulatory requirements.

They assist in the execution of quality processes and contribute to the overall quality control and quality assurance activities within the organization.

Responsibilities :

Assist in the development and implementation of quality systems, policies, and procedures in compliance with applicable regulations and guidelines.

Support the review and approval of manufacturing and testing documents, including batch records, protocols, specifications, and standard operating procedures (SOPs).

Participate in the execution of quality control activities, such as sampling, testing, and inspection of raw materials, intermediates, and finished products.

Assist in investigations of deviations, out-of-specification results, and non-conformances, and contribute to the implementation of corrective and preventive actions (CAPAs).

Support the maintenance of the document control system, ensuring accurate and up-to-date records of quality-related documentation.

Assist in internal audits and participate in regulatory inspections, as required.

Contribute to the training and awareness programs related to quality systems and Good Manufacturing Practices (GMP) for employees.

Assist in the monitoring and trending of quality data, including quality metrics and key performance indicators (KPIs).

Collaborate with cross-functional teams, including Manufacturing, Quality Control, Regulatory Affairs, and R&D, to ensure effective communication and resolution of quality-related issues.

Stay updated on regulatory requirements, industry trends, and best practices related to quality assurance.

Requirements :

Bachelor's degree in a relevant scientific field, such as Pharmacy, Chemistry, or Life Sciences.

Basic understanding of GMP and regulatory guidelines in the pharmaceutical industry.

Strong attention to detail and ability to follow procedures accurately.

Good communication skills, both written and verbal.

Ability to work effectively in a team-oriented environment.

Proficient computer skills, including MS Office applications.

A proactive and self-motivated approach to work, with a willingness to learn and grow in the field of quality assurance.

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

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