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

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.
• 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.