Overview
Sr. Quality Engineer Jobs in Alachua, Florida, USA at ZipRecruiter
Job Description
Location:
Alachua, FL
RTI Surgical is now Evergen!
This rebranding reflects our strategic evolution as a leading CDMO in regenerative medicine and comes after a significant year for the business, including acquisitions of Cook Biotech in IN and Collagen Solutions in MN. Our new brand emphasizes our unique position 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. Headquartered in Alachua, FL, with manufacturing facilities in West Lafayette, IN;
Eden Prairie and Glencoe, MN;
Neunkirchen, DE;
Glasgow, UK; and Marton, NZ, Evergen offers a differentiated portfolio of allograft and xenograft biomaterials at scale.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here:
Responsibilities
Serve as a lead core team member of cross-functional project teams responsible for coordinating process improvements across manufacturing.
Supervise the Quality Assurance Engineering team, including performance management, corrective actions, hiring, and allocation of support related to quality initiatives.
Review quality KPIs and actions to ensure continuous improvement in collaboration with operations.
Review validations and risk management activities supporting regulatory submissions, ongoing activities, and product launches, maintaining high customer and patient focus.
Lead problem-solving efforts through change management, nonconformance workflows, and continuous improvement or new product development initiatives.
Review and edit nonconformance investigations and assist in preparing materials for quality initiatives.
Maintain a strong understanding of microbiology principles related to environmental control, monitoring, cleaning, and sterilization, including gamma irradiation.
Possess working knowledge of risk management principles, FDA, and ISO regulations.
Oversee validation and qualification of facilities, processes, equipment, and systems related to sterility assurance, including aseptic processing.
Perform other duties as assigned.
Minimum Requirements
Education: Bachelor’s degree in biology or microbiology
Experience: 5+ years in Laboratory, Quality, or Manufacturing
Certification: AATB Certification
Skills
Strong analytical and problem-solving skills
Ability to manage multiple projects and investigations
Excellent communication and leadership skills
Project management capabilities
Problem-solving methodologies
Experience with quality management system software
Additional Information
Travel: N/A
Physical Requirements:
Move or lift objects up to 25 pounds
Frequent standing or sitting while using digital displays
Frequent fine manipulation using hands and fingers
Working Environment:
Onsite office environment or remote home office with minimal distractions
More about Evergen
Evergen provides end-to-end services in regenerative medicine, emphasizing quality, integrity, and patient safety, with core values including accountability, agility, growth mindset, customer-centricity, and inclusivity.
We are committed to fostering an inclusive workplace, embracing diversity, and promoting continuous learning and improvement.
Montagu Private Equity acquired RTI in 2020, supporting our transformation to the next level of potential.
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Title: Sr. Quality Engineer
Company: ZipRecruiter
Location: Alachua, Florida, USA
Category: Quality Assurance – QA/QC (Quality Engineering)
