Sr. Quality Engineer

3 weeks ago Be among the first 25 applicants

This range is provided by Evergen. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$90,000.00/yr - $/yr

Location: Alachua, FL

RTI Surgical is now Evergen!

This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes at the end of a significant year for the business, including the successful acquisitions of Cook Biotech in IN and Collagen Solutions in MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.

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, DE, Glasgow, UK, and Marton, NZ.

Read more about this change and Evergen’s commitment to advancing regenerative medicine here:

• 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
• Statistical techniques

• 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 for continuous learning.
• Customer-Centric:
  We prioritize customers at every touch point.
• Inclusive:
  We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.

At Evergen, we are committed to fostering an inclusive workplace where we embrace the richness of our…