QUALITY SYSTEM MANAGER
Reports to: Operations/Engineering (General) Manager
Summary:
This position is responsible for managing the MMT Quality Management System (QMS) and Quality Inspection Supervisor. They are responsible for managing key QMS metrics and ensuring QMS processes are adequately defined and implemented, meeting regulatory and company requirements. They provide expertise on regulatory requirements for the business. They use information gathered from audits, corrective actions, inspection data and observations to initiate and drive continuous improvement within the QMS. They partner with Production and Business Development facilitating and supporting company growth and business objectives.
Duties/Responsibilities include but are not limited to:
- Maintain a high level of professionalism, integrity, and leadership consistent with the organization’s values and principles and holds all direct reports accountable to the same standards.
- Represents MMT as the Quality System Management Representative.
- Manages key QMS processes including but not limited to Change Control and Record Management, Supplier Controls, Quality Inspection and Product Release, Product Issue Management and CAPA Process, Auditing (internal and external), Training, Quality Agreements and Customer Compliance Support, and Management Review.
- Champions compliance to QMS and facilitates compliance with all applicable regulatory and company requirements.
- Compiles and manages Quality System metrics and communication of results to all levels of the organization
- Support Quality Inspection Supervisor on metrology solutions and inspection challenges.
Accountabilities:
- Follows all Quality procedures/policies ensuring that QMS requirements are achieved in an ethical manner.
- Maintains current knowledge of applicable regulations and standards associated with the Quality System.
- Implements Quality System Process: Publish corporate metrics and coordinates Management Reviews.
- Meets company goals for timely actions within QMS process including Complaint and CAPA activities.
- Meets commitments on time, in full, and with accuracy and attention to detail.
- Represents company in positive and appropriate manner with customers, regulators, and suppliers.
- Actively manages performance of team members and provides timely feedback to team members regarding their performance.
Training/Education/Experience:
- Minimum 5 years of experience in a medical device manufacturing environment with Quality experience.
- Experience with medical device manufacturing QMS compliance.
- 4-year Bachelor’s Degree in an appropriate discipline.
- Experience in performance management, training, mentoring, and development of others. 400 Apollo Drive, Lino Lakes, MN Revised: 5/14/2024
- Experienced with ISO 13485 requirements and lean manufacturing.
- Experience with failure investigation techniques, root cause analysis, problem solving, and CAPA processes.
- Strategic planning and implementation skills (project management skills).
- Proficient PC skills to include Microsoft Office (Excel, Word, PowerPoint, Project) and SQL Queries. Familiar with ERP systems and data retrieval.
Competencies/Talents/Personal Attributes:
- A thorough understanding of medical manufacturing, its environment and protocols.
- Ability to accurately assess, develop, and retain the talent of associates, while having the courage and conviction to professionally communicate short comings and, as appropriate, move underperforming employees out of the organization.
- Independent worker with appropriate risk management.
- Ability to effectively implement and execute on plans.
- Strategic and tactical development and implementation.
- Excellent communication skills, written and verbal, in English.