Quality Compliance Engineer

Pfizer • Rochester, MI

3d • Onsite

About The Position

The Quality Compliance Engineer supports the Quality Organization by ensuring compliance with applicable regulatory requirements, company quality systems, and current Good Manufacturing Practices (cGMP). This role plays a key part in driving continuous improvement initiatives, leading quality‑related projects, and partnering cross‑functionally to strengthen compliance, efficiency, and inspection readiness across the site.

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 as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.
• Experience in Quality Assurance, Quality Compliance, or Engineering support roles.
• Experience leading continuous improvement or remediation initiatives.
• Familiarity with root cause analysis, risk management, and quality metrics.
• Experience supporting regulatory inspections and audits.
• Knowledge of electronic quality management systems (eQMS).
• Ability to work in manufacturing and controlled environments, including gowning requirements.
• All candidates applying mist NOT be allergic to penicillin.
• Permanent work authorization in the United States.

Nice To Haves

• Continuous improvement mindset.
• Project planning and execution.
• Regulatory and compliance expertise.
• Problem solving and data‑driven decision making.
• Cross‑functional collaboration and influence.
• Attention to detail with a focus on sustainability and effectiveness.

Responsibilities

• Lead and support continuous improvement initiatives focused on strengthening quality systems, reducing repeat deviations, and improving right‑first‑time execution.
• Apply root cause analysis tools (e.g., 5 Whys, Fishbone, data trending) to identify systemic issues and drive sustainable solutions.
• Partner with cross‑functional teams to simplify processes, improve documentation quality, and enhance compliance efficiency.
• Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.
• Provide quality oversight and guidance for engineering activities such as equipment qualification, process validation, and facility or utility changes.
• Participate in risk management activities (e.g., FMEA, hazard analysis) to support robust design and compliant execution.
• Support development and monitoring of quality metrics to identify trends, risks, and opportunities for improvement.
• Partner with Manufacturing, Engineering, Validation, Supply Chain, and Quality teams to ensure compliant execution of site activities.

Benefits

• 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
• health benefits to include medical, prescription drug, dental and vision coverage
• Relocation support available

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level