This role supports all quality initiatives and is responsible for quality control inspection of incoming materials and in-process manufacturing. This position supports audits and reviews/analyzes data and documentation.
You will:
- Perform dimensional, visual and functional inspections of raw materials, components, finished assemblies and in-process manufacturing work.
- Document inspection results clearly and completely.
- Disposition materials and enter transactions in our ERP system.
- Review supplier test results and First Article Inspections (FAI) reports.
- Support RA/QA associates on defect awareness, inspection methods and specification requirements.
- Maintain knowledge of all procedures and changes to specifications related to areas of responsibilities.
- May perform First Article inspections.
- Review Device History Records (DHRs) for product release.
- Write and distribute non-conformance reports (NCMRs) for nonconformances found during inspection.
- Inspect various plastic and metal components, mechanical instruments, circuit boards, electro-mechanical assemblies, labels and packaging materials
You need:
- 6+ years Inspection experience in medical device or similar industry (i.e., aerospace, automotive or other highly technical, regulated and rapid-paced environment)
- Excellent written and verbal communication skills
- Ability to work as a collaborative team member as well as independently
- Flexibility and strong organizational skills with ability to prioritize multiple tasks
- Experience using calipers, micrometers, height gages, gage blocks, microscopes and similar inspection tool
- Experience with ERP / MRP software systems, especially conducting material transactions
- Ability to initiate and manage time effectively without direct supervision
- To know how to read and interpret engineering drawings, ANSI-Y-14.5 Dimensioning and Tolerancing
- Sound judgment when making decisions and communicating with peers and management
- Excellent attention to detail, producing high quality output appropriate
- To be results-oriented with appropriate urgency and follow-up
We offer:
- Competitive compensation including bonus and equity
- Opportunities for career advancement
- Full benefits package
- An evolving, engaging culture and workplace
Please note that we are unable to provide any type of sponsorship at this time.
