- High-Manufacturing Environment with both Medical and Chemical components
- Direct access to manufacturing floor allows hands-on functionality with product
About Our Client
Our client is committed to fulfilling the exacting demands of medical manufacturing across all major geographic hubs. Their single-source products, in-house R&D bench, and proprietary processes allow them to deliver precise custom coatings that meet or exceed customer expectations. They specialize in coatings that provide surface protection and non-stick applications to medical devices.
The Quality Engineer will be responsible for:
- Manages and reports on product related nonconformities, including but not limited to NCR's, RMA's, CAR's, PAR's and SCAR's.
- Manage and monitor supplier performance for compliance and delivery times.
- In conjunction with Customer Service, review customer drawings and specifications to determine measurement methods and quality plans.
- Collaboration with Engineering to develop and conduct process validation (IQ/OQ/PQ), risk analysis (PFMEA), experimental design (DOE) and Test Method Validation along with the PCCI Engineering team.
- Responsible for ensuring that areas of responsibility are clean, safe and support a positive working environment for employees.
- Identifies and assigns investigation actions.
- Responsible for assessing and developing inspection methods, test methods and tools for Operations.
- Responsible for compliance of the facility calibration program for metrology and process equipment.
- Responsible for writing and revising SOPs, work instructions and Quality Management Systems documentations as necessary.
- Responsible for ensuring all aspects of quality are adhered to and maintained.
MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
The Successful Applicant
The Qualified Quality Manager should have the following:
- Bachelor's Degree in Manufacturing or Industrial Engineering preferred.
- Five years of Quality Engineering experience within an ISO 13485 registered organization is desired.
- Experience with quality engineering tools and principles including process validation (IQ/OO/PQ), risk analysis (PFMEA), experimental design (DOE) and Test Method Validation.
- Experience with supporting a manufacturing facility is a must.
- Experience in PPAP (Production Parts Approval Process) is preferred.
- Sound knowledge of SPC and statistical tools is preferred.
- Experience with gaging methodologies.
- Green Belt/Black Belt Certification
What's on Offer
The following is on offer for the Quality Manager:
- Competitive compensation and benefits
- Mentorship from upper level management
- Internal Growth Opportunities
Please reach out to Cameron Cyker for any inquires. All qualified candidates can expect feedback within 48 hours.