Quality Compliance Engineer
Pfizer
6 months ago
On-site
Michigan, United States
Operations
What You Will Achieve
- Lead and support continuous improvement initiatives to strengthen quality systems, reduce repeat deviations, and improve 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 including equipment qualification, process validation, and facility/utility changes.
- Participate in risk management activities (e.g., FMEA, hazard analysis) to support robust design and compliant execution.
- Partner with Manufacturing, Engineering, Validation, Supply Chain, and Quality teams to ensure compliant execution of site activities.
HERE IS WHAT YOU NEED (Minimum Requirements)
- Bachelor’s with 4+ years; OR Master’s with 2+ years; OR PhD with 0+ years; OR Associate’s with 8 years; OR High school (or equivalent) with 10 years 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).
BONUS POINTS IF YOU HAVE (Preferred Requirements)
- 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.
Physical/Mental Requirements
- Ability to work in manufacturing and controlled environments, including gowning requirements.
- Penicillin manufacturing facility: applicants applying must not be allergic to penicillin.
Non-standard Work Schedule/Environment
- 1st shift; occasional off-shift or weekend support may be required.
- Relocation support available.
Other Job Details
- Work location: On Premise.
- Last date to apply: May 1, 2026.
- Relocation assistance may be available based on business needs/eligibility.
- Lead and support continuous improvement initiatives to strengthen quality systems, reduce repeat deviations, and improve 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 including equipment qualification, process validation, and facility/utility changes.
- Participate in risk management activities (e.g., FMEA, hazard analysis) to support robust design and compliant execution.
- Partner with Manufacturing, Engineering, Validation, Supply Chain, and Quality teams to ensure compliant execution of site activities.
HERE IS WHAT YOU NEED (Minimum Requirements)
- Bachelor’s with 4+ years; OR Master’s with 2+ years; OR PhD with 0+ years; OR Associate’s with 8 years; OR High school (or equivalent) with 10 years 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).
BONUS POINTS IF YOU HAVE (Preferred Requirements)
- 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.
Physical/Mental Requirements
- Ability to work in manufacturing and controlled environments, including gowning requirements.
- Penicillin manufacturing facility: applicants applying must not be allergic to penicillin.
Non-standard Work Schedule/Environment
- 1st shift; occasional off-shift or weekend support may be required.
- Relocation support available.
Other Job Details
- Work location: On Premise.
- Last date to apply: May 1, 2026.
- Relocation assistance may be available based on business needs/eligibility.