Quality Compliance Engineer

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.

• 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).

• 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.

• Ability to work in manufacturing and controlled environments, including gowning requirements.
• Penicillin manufacturing facility: applicants applying must not be allergic to penicillin.

• 1st shift; occasional off-shift or weekend support may be required.
• Relocation support available.

• Work location:
  
  On Premise.
• Last date to apply:
  May 1, 2026.
• Relocation assistance may be available based on business needs/eligibility.