This person is primarily responsible for providing technical leadership to ensure customer requirements are understood and met. Work cross functionally with Development Engineering in IQ, OQ, and PQ validation plans and confirmation of test results and with Operations in research of root cause identification and corrective actions in support of CAPAs.
The Quality Assurance Engineer is primarily responsible for providing technical support to ensure customer requirements are understood and met. In addition, the Quality Assurance Engineer is responsible for providing support to the leadership team to ensure our Quality Management System is maintained.
Specific duties and responsibilities:
- Support and/or lead qualification including IQ, OQ, PQ and process validations to ensure conformance with customer specifications; representing CMD for internal and external audits.
- Champion or lead quality assurance, nonconforming material review/reporting and/or continuous improvement initiatives in reduction of 100% final inspection and reduction of material scrap.
- Lead CMD’s QMS (Quality Management System) to ensure process via SOP’s (Standard Operating Procedures), and procedures via WI’s (Work Instructions) support CMD’s Quality Statement, meet regulatory/ISO requirements and support strong business ethical practices.
- Interface with Engineering and Operations to ensure development and transition of process and procedures from prototype to pre-production to full production.
- Promote strong GMP (Good Manufacturing Practices) and principles as well as DMP (Good Documentation Practices) and principles throughout the organization.
- Evaluate, authorize and remove Suppliers as Approved Suppliers of materials used on Bill of Materials.
Experience and education requirements:
- Bachelor Degree in Engineering/Sciences or equivalent experience in medical device and quality control. Class II or III medical device and extrusion experience strongly preferred. Effective root cause analysis skills.
- Minimum of 3-5 years of experience in medical manufacturing environment. Strong communication and use of statistical process (SPC) methods in reduction of 100% final inspection of products preferred.
- Previous experience in contract manufacturing and complex catheter delivery systems strongly preferred.
Benefits: Medical, Dental, and 401K