Quality Engineer IV
| Company | Omnicell |
|---|---|
| Location | Cranberry Twp, PA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- Bachelor degree in Engineering or Science or Quality management discipline
- Minimum six (6) years’ experience in a quality/manufacturing environment
- Experience working with complex electro-mechanical systems
- Experience with broad variety of measurement and quality data analytic techniques
Responsibilities
- Lead projects related to manufacturing continuous improvements
- Assist in the establishment of quality acceptance criteria and activities including but not limited to incoming, in-process and final inspection
- Participate as Material Review Board member to assist in disposition of non-conforming materials
- Work with manufacturing to document, markup, and communicate changes to parts and assemblies within change control process
- Collaborate with design quality and engineering personnel to determine critical part features and review manufacturability of design
- Participate in change control activities
- Lead in the support of new product introductions to ensure QMS requirements are followed, including Process Verification and Validation activities and pFMEAs
- Ensure compliance to internal QMS documentation and ISO 13485
- Act as a change agent who accepts and supports new ideas and processes
- Manage and/or participate in CAPAs as required
- Act as a liaison between Quality and other Omnicell functional departments
- Update/creation of internal procedures, as required
- Lead or participate in Quality Management Review meetings
Preferred Qualifications
- ISO 13485 or FDA regulated medical device experience
- Robotics experience
- SAP experience