Sr. Quality Engineer

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Full-Time Alachua, FL, US

Salary Range: $90,000.00 To $ Annually

Location: Alachua, FL

Annual Bonus Opportunity 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
• Serves as a lead core team member of cross functional project teams whose responsibilities include coordinating deliverables for the improvement of processes across the manufacturing facility
• Supervises the Quality Assurance Engineering team including performance management, corrective action, hiring and selection, and allocation of engineering support as it relates to quality assurance initiatives
• Reviews quality Key Performance Indicator (KPI) data and actions to ensure continuous improvement in collaboration with various operations value streams
• Reviews validations and risk management activities to support regulatory submissions, sustaining activities, and product launches are on time and have a high level of customer and patient focus
• Leads and conducts problem solving through change management, nonconformance workflows, and continuous improvement or new product development initiatives
• Reviews and edits nonconformance investigation and disposition phases for team members and assists in the preparation and presentation of materials for quality initiatives
• Other duties as assigned

• Bachelor’s degree in relevant technical discipline

• 6+ years of relevant medical device, pharmaceutical, or other regulated industry experience.
• * Combination of advanced degree and experience may be considered.

• 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

• N/A

• 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…