Role: Quality Assurance (QA) Specialist Medical Device Manufacturing Location Pleasanton CA Duration: Long Term Contract Responsibilities: - Minimum of 46 years of experience in quality assurance within the medical device manufacturing industry.
- Strong knowledge of validation protocol and other relevant medical device standards.
- Experience with process validation risk management CAPA RFA and validation protocols in a manufacturing environment.
Skills: - Excellent understanding of Quality Management Systems (QMS) and regulatory requirements in the medical device industry.
- Strong problemsolving skills with a focus on root cause analysis CAPA and continuous improvement.
- Ability to work collaboratively with crossfunctional teams and communicate effectively at all levels of the organization.
- Proficient in the use of quality tools such as Six Sigma PFMEA and statistical process control (SPC).
Certifications (Preferred):
Certified Quality Engineer (CQE) Certified Quality Auditor (CQA) or similar certifications.