# Manager of Medical Device Quality Assurance

**Company**: Pfizer
**Location**: Chesterfield, Missouri
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $99,200.00 to $165,400.00
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Missouri---St-Louis---Chesterfield/Quality-Assurance-Manager--Medical-Device---Combination-Products_4966210-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_ce996e12-71e

## Description

At Pfizer, you will contribute to the development, maintenance, and compliance of medical devices and combination products. As a Manager of Medical Device Quality Assurance, you will oversee global quality assurance for multiple medical device programs, providing technical expertise and risk-based guidance to cross-functional teams.

**Key Responsibilities:**

- Lead global quality assurance oversight for multiple concurrent global MDCP programs and next-generation delivery platforms.

- Serve as a MDCP quality partner for global cross-functional teams, providing authoritative, risk-based guidance on design controls, post-approval changes, and supplier/component changes.

- Drive the resolution of complex, multi-regional business-critical quality and compliance issues.

- Monitor shifting international regulations and translate evolving requirements into unified 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, provide sound recommendations, and enable practical, compliant decisions.

- Identify and drive opportunities to strengthen processes, improve consistency, and advance quality system maturity.

**Requirements:**

- 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.

- 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.

- 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.

**Preferred Qualifications:**

- Experience in both medical device and pharmaceutical quality environments, especially combination products.

- Strong experience with design controls and risk management across the product lifecycle.

- 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.

**What We Offer:**

- Annual base salary ranging from $99,200.00 to $165,400.00.

- Eligibility to participate in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary.

- Eligibility to participate in our share-based long-term incentive program.

- Comprehensive benefits package, including 401(k) plan with Pfizer Matching Contributions, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits.

## Skills

### Required
- Medical Device Quality Assurance
- Regulatory Compliance
- Risk Management
- Quality System Requirements
- Design Controls

### Nice to have
- Combination Products
- Post-Market Surveillance
- Complaint Evaluation
- Periodic Product Review
- Remediation Activities

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/United-States---Missouri---St-Louis---Chesterfield/Quality-Assurance-Manager--Medical-Device---Combination-Products_4966210-2?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)