Senior Quality Engineer
Evergen
Summary
Education: Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
Job description
Responsibilities
- Act as quality lead for major design and manufacturing projects, ensuring robust risk management and compliance.
- Own and optimize quality system processes (e.g., CAPA, supplier quality, complaint handling, statistical techniques).
- Lead complex investigations and implement systemic corrective/preventive actions.
- Provide expertise in reliability engineering, process validation, and design for quality.
- Represent the company as a quality expert during FDA inspections, notified body audits, and supplier audits.
- Collaborate with executive leadership to align quality strategies with business objectives.
- Mentor and coach quality engineers across multiple sites or functions.
Requirements
Education: Bachelor’s or Master’s degree in engineering, life sciences, or related discipline.
Experience: 6+ years of progressively responsible quality experience in the medical device industry.
Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP).
Proven success leading cross-functional projects and influencing at senior levels.
Advanced statistical analysis, risk management (ISO 14971), and Six Sigma Black Belt preferred.
Track record of leading successful audits and remediation projects.
Certification: AATB or CTBS Certification, preferred; Lead Auditor Certification, preferred; ASQ – CQE, CBA, or CQA, preferred.
Skills: Excellent verbal and written communication; Technical writing; Problem solving methodologies; Microsoft Office Suite; Quality Management System software; Investigations; Statistical techniques.
Travel: Up to 25% including international.
Requirements
- Bachelor’s or Master’s degree in engineering, life sciences, or related discipline
- 6+ years of progressively responsible quality experience in the medical device industry
- Deep knowledge of global regulatory standards (FDA QSR, ISO 13485, EU MDR, MDSAP)
- Proven success leading cross-functional projects and influencing at senior levels
- Track record of leading successful audits and remediation projects
- Excellent verbal and written communication
- Technical writing
- Problem solving methodologies
- Microsoft Office Suite
- Quality Management System software
- Investigations
- Statistical techniques
- Travel up to 25% including international
Benefits
- Paid Time Off
- 401(k) With Up to 6% Company Match
- Holiday Pay
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Short-Term Disability Coverage
- Long-Term Disability Coverage
- Paid Parental Leave
Company overview
Evergen is a leading global Contract Development and Manufacturing Organization (CDMO) specializing in regenerative medicine solutions. Founded in 1998 and headquartered in Alachua, Florida, the company operates as a strategic partner to Original Equipment Manufacturers (OEMs) across multiple medical specialties including plastic and reconstructive surgery, sports medicine and orthopedics, neuro/spine, and cardiac applications. Evergen distinguishes itself as the only regenerative medicine CDMO offering a comprehensive portfolio of both allograft and xenograft biomaterials at scale, providing customers with unbiased, needs-driven solutions. The company maintains over 280,000 square feet of cutting-edge medical device manufacturing space worldwide, featuring Class 5-7 clean rooms and Class III PMA-ready facilities. With ISO 13485 certification and FDA/USDA registration, Evergen delivers end-to-end services spanning research and development, regulatory support, manufacturing, and supply chain management. The company's patient-first approach focuses on developing customized biomaterial solutions that promote healing, accelerate recovery, and prevent complications, positioning Evergen as a trusted partner in advancing regenerative medicine technologies.