Quality Assurance Manager – Medical Device, Combination Products

Pfizer

. Lead global quality assurance oversight for multiple concurrent global medical device and combination product programs and next-generation delivery platforms .

Posted 10/21/2026full-timeUnited StatesSeniorLead💰 $99,200 - $165,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance for medical devices and combination products, with a strong focus on risk management, design controls, and compliance within highly regulated environments. Proven ability to collaborate across cross-functional teams and drive quality system improvements.

Highest-signal resume keywords

Quality Assurance ExperienceDesign Controls KnowledgeRisk Management ExpertiseGMP Manufacturing ExperienceStrong Communication Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality System RequirementsProcess ValidationPost-Market SurveillanceChange ControlInvestigation EvaluationCAPA RelevanceProduct RemediationObsolescence PlanningLifecycle ManagementAnalytical Skills

Soft Skills

Collaboration SkillsInfluencing SkillsDecision-Making Skills

Industry Keywords

Medical DeviceCombination ProductPharmaceuticalGMPRegulatory ComplianceCross-Functional TeamsQuality PoliciesQuality DocumentationRisk AlignmentInternational Regulations

About the role

Key responsibilities & impact

Lead global quality assurance oversight for multiple concurrent global medical device and combination product programs and next-generation delivery platforms
Serve as a medical device and combination product quality partner for global cross-functional teams
Provide risk-based guidance on design controls, post-approval changes, supplier/component changes, manufacturing transfers, periodic product reviews, post-market surveillance, product remediations, and obsolescence planning
Drive resolution of complex, multi-regional quality and compliance issues
Monitor international regulations and translate evolving requirements into global policies, procedures, and quality system practices
Evaluate investigation content for completeness, scientific rationale, issue linkage, risk alignment, and potential CAPA relevance
Partner with teams to resolve complex quality issues and enable compliant decisions
Identify and drive opportunities to strengthen processes and advance quality system maturity
Promote consistent interpretation and application of quality policies and procedures
Apply technical expertise to verification, validation, process validation, stability-related considerations, and sustaining lifecycle management of marketed products
Travel across Pfizer manufacturing sites, vendors, and suppliers as needed
Work as an independent contributor without direct reports

Requirements

What you’ll need

Bachelor's degree with at least 4 years of experience; OR master's degree with at least 2 years of experience; OR PhD with 0+ years of experience; OR associate's degree with 8 years of experience; OR high school diploma (or equivalent) and 10 years of relevant experience
Experience working in Quality Assurance, GMP manufacturing, pharmaceutical, medical device, combination product, or another highly regulated industry
Working knowledge of design controls, risk management, and quality system requirements relevant to medical devices, 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
Candidates must be authorized to be employed in the U.S. by any employer
Permanent work authorization in the United States is required
U.S. work visa sponsorship is not available now or in the future

Benefits

Comp & perks

Global Performance Plan with a bonus target of 12.5% of base salary
Share based long term incentive program
401(k) plan with Pfizer Matching Contributions
Additional Pfizer Retirement Savings Contribution
Paid vacation, holiday and personal days
Paid caregiver/parental and medical leave
Medical, prescription drug, dental and vision coverage
Relocation support may be available
Business travel across Pfizer manufacturing sites, vendors, and suppliers
Relocation assistance may be available based on business needs and/or eligibility