What are the responsibilities and job description for the Sustaining Quality Engineer position at Cypress HCM?
A medical device client is looking for a Sustaining Quality Engineer in Forest Lake, Minnesota. This person will lead product requalification activities to ensure continued compliance with internal and external requirements.
Day To Day
Day To Day
- Develop, review, and implement engineering change protocols for updates and modifications to production products.
- Perform data analysis and generate technical reports to support product changes, validations, and quality improvements.
- Serve as the primary quality contact for customer interactions related to production support, complaints, and inquiries.
- Act as the voice of the customer within internal teams to ensure feedback is addressed and integrated into quality processes.
- Investigate and determine root cause of product quality issues and customer complaints and implement effective corrective and preventive actions.
- Collaborate with cross-functional teams including Management, Operations, Estimating, Purchasing, and Customer Service to resolve quality issues and support production needs.
- Ensure compliance with FDA, ISO, and other applicable regulatory standards.
- Support internal and external audits by preparing documentation and participating in audit activities.
- Maintain and update inspection plans, methods, and documentation for sustaining products.
- Drive continuous improvement initiatives related to procedures, workflows, and product quality.
- Support CAPA activities and ensure timely closure of quality events.
- Bachelor’s degree in quality or equivalent experience.
- Minimum 5 years of experience in quality engineering within medical devices, Aerospace & defense or regulated manufacturing environments.
- Experience with plastic injection molding is a huge plus
- In depth knowledge and understanding of contract manufacturing processes
- Knowledge of print reading, including GD&T
- Knowledge of inspection methods, measuring equipment
Salary : $90,000 - $125,000