Address
Form of workJob Description
Duties/Responsibilities:
- Receiving Inspection
- Inspect and test Class III device components and materials
- Documentation review acumen
- Maintain and update applicable trackers
- Initiate nonconformance records and support on investigations
- Maintenance of quarantine cages and rejected materials
- Production
- Conduct in-process inspections, testing and product release activities
- Initiate nonconformance records and support on investigations
- Maintenance of quarantine cages and rejected materials.
- OQ-PQ validation inspections as required
- Documentation/Records
- Records filing, scanning and retention
- Ensure GDP guidelines are properly followed
- Equipment calibration and preventative maintenance support as required
- General QMS and project support as required
- General manufacturing support as required
Special Knowledge/Skill:
- Strong computer skills: Microsoft Office (Word & Excel), Adobe Acrobat and SharePoint
Strong written and oral communication skills; effective communication. - Ability to work on multiple tasks simultaneously with minimal supervision
- Ability to work independently and as a team member
- Familiarity with ISO, FDA, TGA and EU requirements related to traceability, compliance, risk and product manufacturing
Experience:
- 3 - 5 years’ medical device industry experience required
- Ability to use multiple inspection tools (calipers, micrometers, gauges, etc.) required
- CMM experience a plus
- Microbiology/Laboratory experience a plus
- Electronics experience a plus
Education/Training:
- High school diploma or GED preferred
- Current IPC soldering certificate desired
Position Location:
· Ventura, CA
