Senior Manager, Quality Engineering and Operations
This hands on managerial role oversees a small team of quality staff and is responsible for manufacturing quality engineering, product quality control, inspection and test, calibration, environmental monitoring, and supplier management. This role directly supports the company’s manufacturing process development activities and ensures products are soundly engineered and properly manufactured and labeled prior to release.
Knowledge of medical device quality system regulations and compliance requirements are required, as is a proven aptitude to improve existing systems and processes.
Required experience: A minimum of 10 years in the medical device industry with at least 5 years in a quality leadership role.
Education: A minimum of a 4 year degree, preferably in an engineering or science discipline.
Skills, Knowledge, and required Expertise:
• Excellent understanding and practical application of medical device quality system regulations
• Process Validation
• ISO 13485:2016
• EtO Sterilization (ISO 11135)
• Environmental Monitoring (ISO 14698, ISO 14698-2, ISO 14644-1, ISO 14644-2)
• Experience hosting FDA and Notified Body inspections
• Supplier management and auditing
• Inspection and Test methods
• Auditing experience
• ASQ certification (e.g. CQE) a plus
• Familiarity with sterilization processes and validation techniques
• Statistical techniques and data analysis
Inquiries, please contact email@example.com