Quality Manager - Medical Molding
About The Position
The Quality Manager is responsible for ensuring the site’s Quality Management System (QMS) is established, implemented, effective, and compliant with ISO 13485 and 21 CFR 820. The role oversees complaint management, system audits, continual improvement, statistical methods, and quality-related validation activities. The Quality Manager also champions lean manufacturing and continuous improvement to help the Management Team optimize systems. The position manages the site Master Validation Plan, including new process validations and maintenance of existing validations. This includes validation planning, protocol development and execution, data collection and analysis, and reporting results. The Quality Manager supports production investigations and corrective actions, oversees CAPA and customer complaint systems, and ensures timely responses and effective follow-up. The role also oversees inspection, metrology, testing, statistical analysis, nonconforming product disposition, and final product inspection, disposition, and release. The Quality Manager develops and administers quality training, provides direction and support to Quality Engineers and Quality Supervisors, maintains customer relationships regarding product quality, and ensures trend analysis informs CAPA and continuous improvement.
Requirements
- Bachelor’s or Master’s degree in a relevant field.
- More than five years of experience in medical device manufacturing.
- In-depth knowledge of ISO 13485 and 21 CFR 820.
- Experience with quality techniques, including sampling plan development, statistical process control, inspection systems, instrument calibration, and design of experiments.
- Good communication and interpersonal skills.
- Good managerial and supervisory skills.
- Basic computer experience.
Responsibilities
- Ensure the Quality Management System is established, implemented, effective, and compliant with ISO 13485 and 21 CFR 820.
- Champion lean manufacturing and continuous improvement activities to help optimize systems.
- Manage the site Master Validation Plan, including new process validations and maintenance of existing validations.
- Plan validations; develop and execute protocols; collect and analyze data; and report validation results.
- Support production personnel in investigating root causes of internal rejects and implementing corrective and preventive actions.
- Maintain an effective CAPA system.
- Administer the Customer Complaint Management system, ensuring timely customer responses, thorough root-cause investigations, corrective and preventive actions, and effectiveness checks before closure.
- Immediately notify Corporate Quality of any known or potential need for a product recall or medical device reporting.
- Ensure internal and external audit findings are addressed promptly and according to customer or regulatory requirements.
- Oversee product inspection and metrology, functional or analytical testing, statistical analysis and reporting of results, and determination of product acceptability.
- Disposition nonconforming products.
- Develop and administer quality training for employees.
- Provide direction, training, and support to Quality Engineers and Quality Supervisors.
- Serve as the responsible authority for inspection, final disposition, and release of products.
- Maintain customer relationships to address product-quality issues.
- Ensure recurring trend analysis supports proactive CAPA and continuous improvement activities.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
