Sr. QC Inspector
3957 Point Eden Way Hayward, CA 94545
Bayside Solutions is seeking a Sr. QC Inspector to be part of our client’ s team in the East Bay. Our client is an immuno-oncology company developing a proprietary oncolytic electroceutical therapy based on its platform. Preclinical studies on solid tumors in murine models has demonstrated that it enables effective local tumor control and initiates an adaptive immune response with a vaccine-like effect by inducing immunogenic cell death.
Our Company Bio: Founded in 2001, Bayside Solutions is one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four-plus years and over 95% repeat business.
Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success!
You can find additional information on our company website at www.baysidesolutions.com.
Sr. QC Inspector
This position will perform inspection and measurement of purchased materials and products in accordance with specified requirements and conforming to cGMP/QSR (21 CFR 820) and ISO 13485 quality systems.
Summary of Responsibilities:
- Perform essential inspection and measurement of incoming materials and products including First Article Inspection of mechanical (sheet metal, machined, molded), cable, and electrical products, using applicable measurement and inspection tools.
- Document and report inspection results as appropriately per documented procedures.
- Document and report of nonconformance using Nonconforming Material Report.
- Participate in material review board (MRB) meeting to review material nonconformance.
- Carry out responsibilities in accordance with the organization’ s policies and applicable laws.
- Support the Quality Policy and Quality System.
- This position requires 5+ yrs. in mechanical inspection and measurement of complex parts and experience working in a regulated medical device industry.
- Mastered the use of quality control disciplines, tools, sampling inspection plan, and analyzing methodologies.
- Good understanding and experience with GD&T standard (ASME Y14.5M-2009)
- Working experience with FDA cGMP/QSR (21 CFR Part 820 & Part 11) and ISO 13485 quality systems requirements are required. Must also have working knowledge and experience in the following areas: Quality Control, Materials Control, Non-Conforming, CAPA, Sterilization, and general Quality Systems compliance.
- Preferred experience with IPC-A-610 F Acceptability of Electronic Assemblies and inspection of electro-mechanical systems.