The Senior Quality Engineer plays a critical role in ensuring that products and processes meet the highest standards of quality and reliability. This position is responsible for leading quality assurance initiatives, developing and implementing quality control systems, and driving continuous improvement across manufacturing and development teams. The Senior Quality Engineer collaborates closely with cross-functional teams including design, production, and supply chain to identify potential quality issues and implement effective corrective actions. This role requires a strategic thinker who can analyze complex data, lead root cause investigations, and influence quality culture throughout the organization. Ultimately, the Senior Quality Engineer ensures that customer expectations are consistently met or exceeded, contributing to the company's reputation for excellence and compliance with industry standards and regulations.
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.
Minimum 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.
Preferred Qualifications:- Certification as ASQ CQE/CQA/CSSBB or equivalent.
- Experience working in regulated industries such as pharmaceuticals, medical devices, or aerospace.
- Familiarity with regulatory requirements including FDA 21CFR, ISO 13485, or AS9100 standards.
- Advanced degree in Engineering, Quality, or related discipline.
- Proficiency with quality management software and ERP systems.
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
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
Timeline: We will be accepting applications on an ongoing basis until position is filled.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
