Location: 3413 11th Street E Glencoe, MN 55336
Hours: 8am – 5pm Monday – Friday on site
Salary: $90,000 – 105,000.00
Bonus eligibility: $15,000.00 annually
Company Summary:
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.
Position Purpose:
Understand customer requirements and support the development and implementation of effective quality control processes to meet customer expectations. Monitor and evaluate the performance of the Quality Management System through data analysis and reporting against established standards. Ensure compliance with applicable regulatory and quality standards.
Key Responsibilities:
- ISO Management Representative for facility.
- Act as liaison between IACUC committee, facility and farms to ensure compliance with all regulatory requirements.
- Review and edit production reporting documentation to ensure traceability and accuracy.
- Collaborate with the Product Manager on Externally Sourced U.S. Tissue to ensure compliance to customer and regulatory requirements.
- Continuously improving and maintaining quality management system certifications and any other certifications within the facility.
- Communicating and working with customers and suppliers. Develop and maintain relationships with key contacts.
- Partnering with cross functional teams to offer guidance for Quality and Supply agreements with customers and critical suppliers.
- Main contact to support third-party audits. (Customers, Registrars, Regulatory Institutions)
- Prepare and/or Approve internal audit schedule and provide input to management meetings.
- Control and manage supplier qualification and evaluation.
- Assist with responses to government regulatory inquiries.
- Work with other functions to resolve quality/process issues and ensure adequate control of material and processes.
- Oversee environmental monitoring and clean room.
- Oversee all Pathogen testing activities .
- Maintain and monitor process equipment validation.
- Write forms, work instructions and Operating procedures as needed.
- Maintain and monitor document control process.
- Verifying and filing daily regulatory documents.
- Maintain knowledge of ISO 13485, GMP and ISO 22442 requirements for manufacturing.
- Maintain knowledge of FDA, ISO, USDA requirements for manufacturing.
- Final sign off for release of new product to production.
- Implementing improvements to production processes that lead to overall increases in product quality.
- Manage quality objectives/metrics within facility.
- Assist with departmental budget activities .
- Coordinate training activities for quality assurance employees.
- Organizing learning and development events for annual trainings, providing career development support to the quality team, managing regulatory training for newly onboarded employees.
- Monitors and evaluates quality assurance personnel as it relates to their job description.
- Leadership within the organization, toward product and organizational excellence.
- Weekly team meetings and monthly one on ones with direct reports.
- Escalation point person on quality and regulatory issues within facility.
- Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices.
- Contribute to team goals and assist with additional responsibilities as needed.
Qualifications:
- Minimum 4 years management/supervision in a manufacturing environment.
- Associate of Arts Degree or Bachelor of Science Degree and/or 6 years' experience in manufacturing and quality.
- 3+ years of leadership skills
- Project Management and problem solving skills.
- Knowledge of risk assessments and risk management principles.
- Understanding of quality system requirements.
- Working knowledge of ISO 13485, ISO 22442-2, GMP, or USDA requirements.
- ISO 13485 Lead Auditor certification or auditing experience preferred.
Other Requirements:
PHYSICAL: Ability to lift and/or carry= 50 lbs.
Why Join Us?
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, MN. Our new brand identity emphasizes our unique positioning as the only CDMO offering a comprehensive portfolio of allograft and xenograft biomaterials at scale.
Read more about this change and Evergen’s commitment to advancing regenerative medicine here: https://lnkd.in/eMSfVJkM ;
As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, 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 headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, IN., Eden Prairie and Glencoe, MN., and Neunkirchen, Germany.
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 diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity (“Montagu”), a leading European private equity firm, acquired Evergen in 2020 and has supported the transformation of the company to its next level of potential.
