Quality Assurance Manager, Medical Device & Combination Products

Pfizer; Saint Louis (MI); Hybrid; USD 99,000 - 165,000; Full time

Job summary

Pfizer is seeking a Quality Assurance Manager for Medical Device & Combination Products in a hybrid role based in the United States. You will provide strategic quality oversight across development and sustaining lifecycles, guiding risk-based decisions and ensuring design controls and quality systems compliance.

The role requires strong collaboration across functions, handling post-market activities, supplier changes, and regulatory readiness to protect patient safety and product quality.

Qualifications

• Bachelor's degree with 4+ years QA/regulated industry experience.
• Master's degree with 2+ years experience.
• PhD with 0+ years experience.
• Associate's degree with 8 years experience.
• High school diploma with 10 years relevant QA experience.

Responsibilities

• Provide quality oversight for MDCP programs across development and sustaining lifecycle.
• Serve as a key quality partner for cross-functional teams; provide risk-based guidance on design controls, risk management, and quality systems.
• Review and approve device complaint investigations with technical rigor and timely closure.
• Monitor regulatory changes and translate requirements into policies and practices.
• Identify opportunities to strengthen processes and advance quality system maturity.

Skills

Quality Assurance

Design controls

Risk management

Cross-functional

Education

Bachelor's degree

Job description

## Quality Assurance Manager, Medical Device & Combination Products申请: United States - Michigan - Kalamazoo: United States - Florida - Tampa: United States - Kansas - McPherson: United States - Massachusetts - Andover: United States - Missouri - St. Louis: 全职: 今天发布: 4959387**USE YOUR POWER FOR PURPOSE**Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.**WHAT YOU WILL ACHIEVE**This role is part of Pfizer’s Medical Device and Combination Products (MDCP) Quality Operations team. In this role, you will serve as a key quality partner supporting development, sustaining, and complaint activities across the product lifecycle. The Manager, Medical Device Quality Assurance, is responsible for ensuring that medical devices and combination products are developed and maintained in compliance with applicable design control requirements and key regulatory standards, including 21 CFR 820, ISO 13485, and ISO 14971. You will provide strategic and technical quality oversight for both complex programs and for complaint investigations, guide risk-based decision-making, and help ensure compliance with applicable design control and quality system requirements. You will work across functions to resolve issues, strengthen processes, and support product quality, patient safety, and regulatory readiness.* Provide quality oversight for MDCP programs across both development and sustaining lifecycle activities.* Serve as a key quality partner for cross-functional teams, providing risk-based guidance on design controls, risk management, quality systems, vendor management, change control, and complaint-related activities.* Support on-market and sustaining activities, including post-approval changes, supplier and component changes, manufacturing transfers, periodic product reviews, post-market surveillance, and product remediation or obsolescence planning.* Assess the quality, safety, and regulatory impact of product and process changes to help ensure continued compliance and maintenance of design and risk management documentation.* Review and approve device complaint investigations with a focus on technical rigor, documentation quality, and timely closure.* Evaluate investigation content for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance.* Partner with teams to resolve complex quality issues, provide sound recommendations, and enable practical, compliant decisions in a fast-paced and highly regulated environment.* Monitor changes in global regulations and help translate evolving requirements into effective policies, procedures, and quality system practices.* Identify and drive opportunities to strengthen processes, improve consistency, and advance quality system maturity across the MDCP development and sustaining space.* Promote alignment in the interpretation and application of quality policies and procedures across teams and activities.* Apply technical expertise across later-phase product lifecycle activities, including verification, validation, process validation, stability-related considerations, and sustaining lifecycle management of marketed products.**HERE IS WHAT YOU NEED** (Minimum Requirements)* Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience working in Quality Assurance, GMP manufacturing environment, pharmaceutical environment, or medical device space.* Experience supporting quality activities in medical devices, combination products, pharmaceuticals, or another highly regulated industry.* Working knowledge of applicable quality and regulatory requirements, such as design controls, risk management, and quality system requirements relevant to medical devices and/or combination products or pharmaceutical products.* Experience supporting product development and/or sustaining lifecycle activities, including change control and ongoing product maintenance.* Ability to work effectively across cross-functional teams and make sound, risk-based decisions in complex or ambiguous situations.* Strong communication, influencing, and collaboration skills.* Strong analytical skills and ability to work effectively with quality documentation, systems, and data.**BONUS POINTS IF YOU HAVE** (Preferred Requirements)* Experience in both medical device and pharmaceutical quality environments, especially combination products.* Strong experience with design controls and risk management across the product lifecycle, from development through launch and post-market sustaining.* Experience supporting on-market product changes, post-approval changes, supplier or component changes, and manufacturing transfers.* Experience with post-market surveillance, complaint evaluation, periodic product review, and remediation activities.* Working knowledge of combination product regulations, including 21 CFR Part 4, and broader medical device regulatory expectations.* Experience partnering with suppliers, vendors, or external manufacturers in a regulated environment.* Experience applying a risk-based approach to complex quality decisions in fast-paced, cross-functional settings.* Familiarity with verification, validation, process validation, usability, software, or other technical development areas relevant to medical device programs.**NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS*** The role may include frequent business travel across Pfizer manufacturing sites, vendors, and suppliers.**OTHER JOB DETAILS**Work Location Assignment: HybridLast Date to Apply for Job: **September 28, 2026**The annual base salary for this position ranges from $99,200.00 to $165,400.00.\\* In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.\\* The annual base salary for this position in Tampa, FL ranges from $89,400.00 to $149,000.00.This role is posted in multiple locations. If you are applying for the role in an secondary job posting location where pay transparency regulations apply, your Talent Advisor will share the local pay information with you during the first interview.Relocation assistance may be available based on business needs and/or eligibility.Candidates must be authorized to be employed in the U.S. by any employer.U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.