What are the responsibilities and job description for the Quality Control Manager position at Evergen?
Location: Onsite in Alachua, FL
RTI Surgical is now Evergen!
This rebrand 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, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.
About Evergen:
Evergen (formally RTI Surgical) 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: https://lnkd.in/eMSfVJkM
JOB RESPONSIBILITIES
- Oversees Quality Control departments/groups such as Manufacturing Records, Biomedical Laboratory, Receiving Inspections, Product Inspection and Testing.
- Develops and implements effective quality practices related to production processes.
- Continuously monitors processes against quality and business objectives and implements process improvements, as necessary.
- Manages the inspection and testing of materials, environment, and product to ensure adherence to established quality standards.
- Proposes and implements new or improved quality control methods, procedures, and/or standards.
- Ensures that project/department milestones/goals are met and adhere to approved budgets.
- Supports the development and implementation of written quality policies and procedures to ensure compliance with all applicable regulations and industry standards.
- Participates in audits and inspections conducted by regulatory agencies and accreditation/certification bodies.
- Manages and mentors Quality Control Supervisors in completing assignments, problem solving/troubleshooting, training, performance appraisals and professional/personal development.
- Oversees and ensures completion of quality personnel priorities to support Operations and Customer Fulfillment activities.
- Manages process for evaluating non-conformances and deviations in Operations and coordinates with Quality Systems group for executing NCs and CA/PAs.
- Develops quality objectives and metrics and provides performance summaries to executive management.
- Supports corporate quality objectives and Quality Systems as applicable at the designated site.
- Other duties as assigned
Education
- Bachelor’s degree in relevant discipline
Experience
- 5 years of quality experience in the medical device, pharma, HCT/P, or biologics industry
- 3 years of supervisory experience
Certification
- N/A
Skills
- Excellent verbal and written communication
- Microsoft Office Suite, intermediate Excel
- Statistical techniques
- Problem Solving Methodologies
- Technical writings
- Quality Management System (QMS) software
Travel
- N/A
SAFETY
Physical Requirement
- Move or lift objects up to 25 pounds
- Frequent (>75%) stationary position (standing or sitting) while utilizing digital
- Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)
Working Environment
- Onsite: Office environment with assigned workstation
- Remote positions only: Home office environment with minimum distractions
