Quality Manager

My client is a leading medical device manufacturer experiencing growth. They are seeking a Quality Manager to oversee and enhance all aspects of quality assurance and quality control. The ideal candidate will have a strong background in quality management systems within the medical device industry.

About the role

As the Quality Manager, you will manage, implement, and continuously develop the company’s Quality Management System (QMS) to ensure compliance with medical device industry requirements.

Responsibilities

• Ensure compliance with FDA Quality System Regulation (QSR), ISO 9001, ISO 13485, and ISO 14971 standards.
• Oversee quality system activities including CAPA, complaint handling, document control, change control, and design control.
• Manage internal and external audits, including preparation, execution, findings, corrective actions, and follow-up.
• Provide quality support for supplier development, supplier controls, process development, and process validation.
• Develop and maintain control plans and quality procedures to ensure consistent product and process compliance.
• Apply knowledge of Good Laboratory Practices (GLP), sterilization equipment, sterilization methods, and related procedures.
• Provide technical and statistical support to Quality Control teams, including data analysis, process monitoring, and problem resolution.
• Support continuous improvement initiatives focused on quality, efficiency, compliance, and overall operational performance.
• Lead and manage quality personnel, including workload planning, performance management, technical mentoring, and team development.

Requirements

• Minimum of 5 years’ experience in the medical device field in roles such as quality engineer, quality control supervisor, auditor, quality assurance, or quality manager.
• Familiarity with machining, metal finishing, sheet metal fabrication, and assembly processes.
• Familiarity with the orthopedic industry.
• Expert understanding of QSR, ISO 9001, ISO 13485, control plans, and ISO 14971.

Qualifications

• A minimum of a Bachelor’s degree in Engineering or a relevant scientific discipline with 7 years of relevant experience, or a Master's degree in the same with 5 years of experience.
• Certifications such as Certified Quality Engineer, Certified Quality Auditor, or Certified Lead Auditor are preferred.
• Six Sigma Green Belt is desirable.
• Training in Lean and 5S is desirable.

Pay

$110,000 - $130,000 per year