Quality Manager

About the role

The ISO Management Representative will oversee the Quality Management System and ensure compliance with regulatory and quality standards.

Responsibilities

• 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.
• Develop and maintain relationships with key contacts.
• Partner 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.
• Aid with responses to government regulatory inquiries.
• Assist with resolving quality/process issues and ensuring 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.
• Verify and file 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.
• Implement 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.
• Organize learning and development events for annual trainings, provide career development support to the quality team, manage regulatory training for newly onboarded employees.
• Monitor and evaluate quality assurance personnel as it relates to their job description.
• Lead 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.
• Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices.

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.
• 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.

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.

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.