Quality Assurance Manager, Medical Device & Combination Products

USE YOUR POWER FOR PURPOSEEverything 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 ACHIEVEThis 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 REQUIREMENTSThe role may include frequent business travel across Pfizer manufacturing sites, vendors, and suppliers.OTHER JOB DETAILSWork Location Assignment: HybridLast Date to Apply for Job: September 28, 2026The 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.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email View email address on click.appcast.io. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.Quality Assurance and ControlSummaryLocation: United States - Michigan - Kalamazoo; United States - Florida - Tampa; United States - Kansas - McPherson; United States - Massachusetts - Andover; United States - Missouri - St. LouisType: Full time