A bit about us:
We design and manufacture the most advanced electromechanical systems for the Medical Device & Pharmaceutical Industries. These systems are used for R&D to clinical to GMP production.Why join us?
- Working on next generation Biotechnology that will save lives
- Growth opportunity to move into management
- R&D environment
- Advanced engineering team to work along side with
- Benefits, 401k, and Stock Options
As the Quality Inspector you will support operations related to the production of our products. This position performs Quality Control (“QC”) inspections incoming materials, components, and in-process products, and will also perform some Quality Assurance (“QA”) functions, such as managing and approving deviation reports (nonconformances), batch record (work order/router) documentation. This role requires experience working in a controlled environment (Clean Room), performing QC and QA functions, compliance to specifications, procedures, and good documentation practices, according to FDA regulations for GMP and ISO 13485. The ideal candidate will have experience with FDA GMP regulated products, i.e., medical device, biotech, or pharmaceutical.
- Quality Control Inspection for materials and components
- Managing and approving Deviation Reports/ nonconformance's
- Experience with small inspection tools (micrometers, calipers)
DUTIES & RESPONSIBILITES:
- Perform inspections for assembled products per procedures and complete related documentation and approvals. Perform sampling and inspection of incoming materials and components per procedures, specification documents, statistical sample plan (eg, AQL), using inspection tools such dimensional measurement, vision systems, and visual inspection.
- Manage batch documentation (work orders and routers) including initiation, review, approval, and filing.
- Review and provide Quality approval for various documents including component specifications, inspection procedures, and standard operating procedures
- Perform or support management of QA records such as nonconformance reports, supplier corrective actions, supplier qualification documents, work orders, internal audits, and CAPAs.
EDUCATION & EXPERIENCE:
- Associate or Bachelor's in Science
- 3+ years of experience performing QC Inspections
- Quality Inspection experience on materials and components.