Description:
The Role Involves
- Utilizing Quality Engineering tools and practices for the effective and efficient development and/or transfer of products/processes into commercial operations
- Utilizing Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision
- Utilizing appropriate risk management to prevent unanticipated failure modes and improve the capability of processes
Responsibilities
- Team member representing the Quality function supporting projects in with a focus on metals forming processes
- Support Quality and Validation activities for product transfers and new product introductions
- Responsible for ensuring conformance with current equipment, process, and systems validation regulations
- Determine the implications of validations upon, Product Quality, Patient Safety, and Data Integrity
- Assess effectiveness of measurement tools, destructive test, non-destructive tests (measurement system analysis)
- Determine process inputs and factors for variation where process capability is required
- Responsible for reviewing Installation, Operating and Performance Qualification (IQ, OQ, PQ) s
- Responsible for conducting Test Method Validations as required
- Develop/Review PFMEA documentation to support processes as part of Validation process
- Partner with other cross functional partners to ensure the correct application of design controls, risk management and the investigation/correction of design failures/challenges
- Conduct investigation, bounding, documentation, review, and approval of non-conformances and CAPAs related to Materials projects. Escalation of quality issues as appropriate
- Support root cause analysis activities related to material processes
- Communicate effectively with internal team on actions and deliverables
- Provide timely and accurate reporting and management of escalations as appropriate on project activities
- Ensure all activities comply with GMP, ISO and quality system requirements
- Ensure that all health, safety, and environmental requirements are fulfilled
Minimum Qualifications and Experience
- BSc in Engineering or Science with 2 years' experience in a medium to high volume manufacturing environment
- 1 year in a similar capacity in a regulated industry (i.e., FDA/ISO)