KC292
Located in:
Kentwood, MI
Pay: $85,000 - $110,000/year, depending on experience
Job Full Description:
A global leader in the manufacturing of orthopedic implants, spinal implants, precision instruments, and orthopedic cutting tools is seeking a Medical Device Quality Manager to join its dynamic team. Specializing in high-precision CNC milling, turning, and cutter grinding, this organization is dedicated to delivering exceptional quality and reliability. Reporting to the Director of Quality and the Site General Manager, the Quality Manager will lead the development and maintenance of a robust quality system that meets ISO 13485 and regulatory standards, ensuring product excellence and compliance.
Quality Manager Responsibilities:
- Lead and mentor Quality Engineers, Supervisors, Technicians, and Inspectors to achieve departmental and organizational goals.
- Ensure product quality by adhering to workmanship standards and improving quality system policies, procedures, and work instructions.
- Develop, maintain, and enhance a quality system compliant with ISO13485, 21CFR820, and other applicable standards.
- Act as the management representative for quality systems, coordinating audits and liaising with regulatory agencies.
- Represent customer interests within the organization, facilitating communication about quality issues and audits.
- Organize and lead quality system management review meetings, tracking outputs and action items.
- Schedule and oversee internal audits, ensuring corrective actions are completed promptly.
- Support continuous improvement initiatives by collaborating with Area Improvement Teams.
- Ensure compliance with customer requirements, including product launches, PPAP, and APQP processes.
- Guide and support gage laboratory personnel and calibration technicians.
- Analyze quality data to identify trends, providing insights and recommendations to management.
- Manage non-conforming products, ensuring proper identification, control, and disposition.
- Address supplier quality issues, assisting with supplier evaluation and development.
- Train and mentor staff in quality-related disciplines, fostering a culture of quality excellence.
- Travel to meet with suppliers, customers, and other sites to resolve quality concerns.
- Oversee process changes, ensuring compliance with change control procedures.
- Maintain quality-related files and records in accordance with standards.
- Ensure the Quality Department is adequately staffed and aligned with budgetary goals.
Schedule:
- Monday-Friday, 6:00 AM - 4:00 PM
Job Experience
- Preferred certifications: American Society for Quality (ASQ) Certified Quality Engineer (CQE).
- Proven leadership and management experience in quality assurance.
- Knowledge of quality tools, ISO standards, and Geometric Dimensioning and Tolerancing (GD&T).
- Strong problem-solving, organizational, and interpersonal skills.
- Proficiency in statistical tools and gaging systems development.
- Ability to lift up to 30 pounds and tolerate contact with cutting fluids and mineral spirits.
Job Education
Bachelor’s degree in Engineering, Quality Assurance, or a related field.
Kentwood, MI
Susan Delauter
Susan.Delauter@SRGexpress.com
+1 616-608-9681
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