Quality Assurance Senior Associate - Medical Device & Combination Products

Use Your Power for Purpose

Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.

The Quality Assurance Senior Associate, MDCP supports product development and sustaining engineering teams by reviewing Design History Files (DHFs) for compliance with CFR 820.30, ISO 14971, and other regulations affecting device and drug-device interfaces. The Senior Associate collaborates across functions to ensure products meet safety and regulatory standards. Your specialized knowledge will contribute to achieving team goals within Pfizer’s quality system, necessitating exceptional communication, analytical, and consensus-building abilities. This role requires a self-motivated professional who can proactively identify and address issues, communicate across all organizational levels, prioritize quality, assist in completing critical deliverables, clarify complex matters, and foster effective teamwork.

What You Will Achieve

In this role, you will:

• Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls, risk management, quality management systems, change controls, vendor management, and complaints.
• Ensure device design, development, commercialization, complaint, and manufacturing documentation of medical devices and MDCPs meet appropriate regulatory requirements by providing guidance through all stages of life cycle management in accordance with 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO
• Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement.
• Provide support for audits and inspections by FDA, notified bodies, competent authorities, and other third parties.
• Provide guidance, recommendations, and support in the authoring of implementation plans for adherence to new regulations, standards, and procedures.
• Well versed in quality investigation techniques. Assist in investigating deviations related to laboratory, design verification, validation, or manufacturing activities.
• Reviews and approves project related documentation including protocols, validations, complaint/non-conformance records, supplier assessments, and quality agreements.
• Interact with functional departments, suppliers, and experts to implement quality goals.
• Apply ISO and QSR requirements to processes and procedures internally and externally.
• Perform other duties as assigned by area management.

Here Is What You Need (Minimum Requirements)

• BA with 2+ years of relevant experience or MBA with 0+ years of relevant experience.
• Technical knowledge related to either pharmaceutical manufacturing/development and/or the design/operation of medical device or drug combination product platforms, design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR.
• Knowledge and application of device root cause analysis methodology and device CAPA requirements
• Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues
• Demonstrated influencing and negotiating skills. High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement
• Demonstrated skills in conducting and documenting quality investigations related to pharmaceutical or medical device manufacturing processes
• Strong understanding of Quality System functions, manufacturing and packaging processes, validations, engineering drawings, and basic statistical processes
• Ability to apply mathematical concepts, particularly statistics and probability, to Quality Engineering tasks
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software

Bonus Points If You Have (Preferred Requirements)

• The combination of pharmaceutical and / or medical device development experience
• Understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems
• Experience in risk management and design control of medical devices, combination products from concept through launch, or pharmaceutical manufacturing operations in a GMP environment
• Proven ability to succeed in a fast-paced, challenging, and complex environment
• Ability to work independently and as part of a team
• Strong interpersonal skills and the ability to communicate effectively with all levels of the organization
• Ability to adapt to changing priorities and manage multiple tasks simultaneously
• ISO 13485 Lead Auditor Certification
• Experience in mentoring and training colleagues
• Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use

Physical/Mental Requirements

Sitting, standing, walking, ability to perform mathematical calculations, and ability to perform complex data analysis.

Non-Standard Work Schedule, Travel, or Environment Requirements

• Onsite OR flex schedule.
• Core business hours 8-5, occasional evening, weekend, and holiday work may be required.
• No routine travel

Other Job Details

Last Day to Apply: November 20th, 2026

The annual base salary for this position ranges from $82,700.00 to $137,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 10.0% of the base salary. 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.

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.

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 Control