Senior Quality Engineer

Responsibilities

• Program ownership of continued process verification (CPV)
• Lead and coach teams on complex investigations; ensure statistical/technical rigor and business continuity.
• Facilitate site PFMEA reviews; institutionalize risk registers; align mitigation control strategies.
• Quality by Design (QbD): Partner with Manufacturing, Science, and Technology (MSAT) for control strategy updates and CPV enhancements; enable Product Process Qualification (PPQ) readiness where applicable.
• Lead continuous improvement projects impacting yield, RFT, and cycle time.
• Co-lead audit front-room topics; lead back-room coordination and commitments tracking.
• Analyze quality data and metrics to identify trends, risks, and opportunities for continuous improvement.
• Train and mentor junior quality engineers and other team members on quality best practices and methodologies.

Qualifications

• Bachelor’s degree in Biomedical Engineering, Quality Management, or a related technical field.
• 5+ years of experience in quality engineering or quality assurance roles within a manufacturing or product development environment.
• Strong knowledge of quality management systems (QMS) and industry standards such as ISO 9001, 21CFRPart 210 and 211.
• Proficiency in root cause analysis tools and methodologies such as 8D, Fishbone diagrams, and FMEA.
• Experience with statistical process control (SPC) and data analysis software.

Benefits

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• Referral Bonus Program with no limit
• Eligible for annual bonus program