Senior Quality Engineer

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Full-Time Eden Prairie, MN, US

9 days ago Requisition

Salary Range: $ To $ Annually

Annual CIP bonus opportunity of up to $10,000.00

Evergen is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, Evergen is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN;
Eden Prairie and Glencoe, MN;
Neunkirchen, Germany;
Glasgow, UK; and Marton, New Zealand.

We are proud to be Great Place to Work® Certified in 2026
, reflecting our commitment to creating an exceptional employee experience and workplace culture. Evergen currently has full-time career opportunities available across multiple locations.

• Paid Time Off (PTO)
• 401(k) with up to a 6% company match
• Holiday pay
• Medical, dental, and vision insurance
• Short-term and long-term disability coverage
• 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.

• 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.
• Advanced statistical analysis, risk management (ISO 14971), and Six Sigma Black Belt preferred.
• Track record of leading successful audits and remediation projects.

• AATB or CTBS Certification, preferred
• Lead Auditor Certification, preferred
• ASQ – CQE, CBA, or CQA, preferred

• Excellent verbal and written communication
• Technical writing
• Problem solving methodologies
• Microsoft Office Suite
• Quality Management System software
• Investigations

• Up to 25% including international

• Move or lift objects up to 25 pounds
• Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
• Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
• Onsite:
  Office environment with assigned workstation
• Remote positions only:
  Home office environment with minimum distractions

Evergen provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management.

Evergen is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:

• Accountable: We own our actions and decisions.
• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.
• Growth Mindset: We embrace challenges as opportunities for continuous learning.
• Customer-Centric: We prioritize customers at every touch point.
• Inclusive: …