Quality Manager
A medical device manufacturer is seeking a Quality Manager to oversee its Quality Assurance and Quality Control functions. This position combines hands-on quality responsibilities with management of the quality department and will oversee a team of Quality Engineers and Quality Inspectors. The Quality Manager will be responsible for the development, implementation and management of the company's Quality Management System while ensuring compliance with applicable medical device regulations and customer requirements. The position works closely with manufacturing, engineering, purchasing, customers, suppliers and regulatory organizations.
Responsibilities
-Manage and monitor all Quality Assurance and Quality Control activities.
-Lead, develop and manage a team of Quality Engineers and Quality Inspectors.
-Manage and continuously improve the company's Quality Management System.
-Maintain compliance with applicable medical device regulations and quality standards.
-Manage the CAPA system, including investigation, corrective action and follow-up.
-Manage document control and quality activities associated with change control.
-Support and oversee quality activities related to design control.
-Lead and support internal and external quality audits.
-Work directly with customers during audits and regarding ongoing quality requirements.
-Support supplier qualification, development, assessment and controls.
-Provide quality support for manufacturing process development and validation.
-Establish quality standards, procedures and best practices.
-Review the work of Quality Department personnel and provide technical guidance.
-Identify staffing, equipment and other resource requirements within the Quality Department.
-Support continuous improvement initiatives throughout manufacturing operations.
-Ensure product designs meet internal quality requirements and applicable regulatory requirements.
Required Experience
-Minimum of 5 years of experience within the medical device industry in Quality Engineering, Quality Assurance, Quality Control, auditing, quality supervision or quality management.
-Experience developing, implementing and maintaining a medical device Quality Management System.
-Knowledge of medical device regulatory requirements and quality systems.
-Knowledge of ISO 13485, ISO 9001 and ISO 14971 requirements.
-1-2+ years Previous people-management experience, including hiring, training, coaching, performance assessment and employee development.
-Experience coordinating multiple quality projects and priorities simultaneously.
-Experience working directly with engineering and manufacturing personnel.
-Experience communicating with customers, suppliers and regulatory organizations.
-Ability to operate as both a department manager and technical quality resource.
-Familiarity with machining, metal finishing, sheet metal fabrication and assembly processes.
Preferred Experience
-Quality experience supporting products within the orthopedic medical device industry.
-Experience with sterilization cases, trays or similar medical device products.
-Certified Quality Engineer (CQE), Quality Auditor (CQA), Lead Auditor.
-Six Sigma Green Belt.
-Lean manufacturing training.
-5S training.
Education
Bachelor's degree in Engineering or a relevant scientific discipline with approximately 7 years of relevant experience; or
Master's degree in Engineering or a relevant scientific discipline with approximately 5 years of relevant experience.
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Pay: $110,000.00 - $130,000.00 per year
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Vision insurance
Work Location: In person
