Menlo Park, CA
PURPOSE OF JOB: Support quality assurance and adhere to QSR and ISO regulations.
MAJOR DUTIES AND RESPONSIBILITIES:
- Perform inspections/ testing activities pertaining to IQC, in-process, final packaging inspection, product lot release, verification /validation testing activities, first article inspections (FAI), and product retain inspection.
- Support day to day manufacturing activities.
- Generate detailed and accurate inspection and testing reports according to Current Good Manufacturing Practices (cGMP) and maintain inspection and testing files.
- Generate and assist in NCMR investigations as assigned.
- Maintain IQC records, QC related logs and databases (e.g. IQC, NCMR).
- Perform QA related data entry and generate reports as required.
- Perform Sterile Load processing and review.
- Process RGA product, as appropriate.
- Assist Quality Engineers, Manufacturing Engineers and R&D Engineers in developing inspection/test procedures, test method validations, and gage studies as assigned.
- Coordinate test requests and shipments to contract laboratories.
- Implement improvements to inspection and test documentation, and Quality System procedures.
- Assist in identifying continuous improvement opportunities.
- Support company goals and objectives, policies and procedures, QSR, and FDA regulations
- Audit production lines to ensure QSR/GMP compliance as assigned.
- Perform Device History Records review and product release activities as assigned.
- Perform other QA related activities as assigned.
- Train new Quality Control Technicians
EDUCATION /EXPERIENCE REQUIREMENTS:
- Associate degree or equivalent industry experience preferred.
- Certified Quality Technician (CQT) or Certified Quality Improvement Associate (CQIA) preferred.
- Minimum of 5 years of experience performing QA inspections/testing activities pertaining to IQA, in-process, lot release and V&V, and administration of various Quality Systems in the medical device industry.
- The ability to understand and follow Quality System Procedures (e.g. SOP and Test Methods).
- Strong understanding of, cGMP, QSR and ISO13485:2003 requirements.
- Working knowledge in reading and interpreting technical specifications and mechanical drawings.
- Strong knowledge of a wide variety of inspection and test equipment, and methodologies.
- Experience with computer-based applications (MS Word, MS Access, MS Excel, ERP)
- Excellent written and verbal communication skills.
- Strong time management skills and the ability to multi-task in a fast-paced environment.
- Excellent organizational skills.