Job Title: QC Inspector III
Job Location: Sunnyvale, CA
Job Requirements: Class II/III Medical Devices, QC Inspection (incoming, in-process, and finished goods), Quality Documentation, MicroVu, Cleanroom experience, strong communication skills
Headquartered in Northern California, we are a public Medical Device company that has pioneered a new approach for the treatment of artery disease.
What You Will Be Doing
The Quality Control Inspector III works with Quality, Operations, Engineering, and Supply Chain to facilitate the inspection and testing of components, assemblies, and products to ensure they meet established specifications and requirements.
Responsibilities:
- Conduct inspections on incoming, in-process, and finished goods
- Perform inspections of components, assemblies, and devices per applicable drawings and specifications.
- Maintains accurate and up to date records of all materials.
- Carefully review and check the accuracy of your own and others work.
- Provide input and support for product testing throughout the lifetime of the product (prototypes, DV&V, post-production, etc.).
- Participate in the initiation and execution of nonconforming product actions.
- Communicate with Engineers, Supply Chain, and other staff to resolve inspection questions.
- Support the ISO, EN, and MDD certification processes and compliance with FDA regulations by ensuring compliance with all applicable policies, procedures, and guidance documents while performing assigned tasks and duties.
- Contribute to a safe work environment by meeting company safety policies and all regulatory requirements.
What You Need for this Position
Must-Have Skills:
- 5+yrs of experience as a QC Inspector in the Medical Device field
- Class II or Class III Medical Device experience
- Incoming, In-Process, and Finished Goods Inspection + LHR Review experience
- Proven background using hand measurements tools (i.e: caliper, snap gauge, pin gauge, micrometer, etc)
- Experience with MicroVu
- Comfortability working in a Cleanroom for long hours, when needed
- Strong Documentation experience (i.e: updating procedures, creating inspection plans, redlining drawings for engineering, protocols, etc)
- Strong communication skills, both verbal & written
- High School diploma required; BA/BS Degree in a technical field highly preferred
Bonus Skills:
- QC Inspection for Catheters
- Catheter Leak Testing
- Experience with ERP Software
- Senior/Lead-level experience with proven ability to take on additional delegated projects
So, if you are a QC Inspector in the Medical Device industry with the above experience, please apply today!
Applicants must be authorized to work in the U.S.
Email me to apply for this position