**Onsite Role in Cypress, CA**
Job opportunity with a top biopharmaceutical company that is looking for a Senior Quality Specialist, Calibration, and PM to join their team on a 6-12 month contract to hire!
Qualifications:
- Minimum of 8 years of experience in Quality Assurance or Manufacturing in the Medical Device industry
- Bachelor's Degree in an applied science or engineering field (preferred) or 6 years equivalent work experience
- Demonstrated competency with 21 CFR 820, ISO 13485
Job Description/Skills:
- Own and maintain the equipment Calibration and Planned Maintenance Quality System for all applicable sites.
- Drive continuous improvement on the Calibration and Planned Maintenance Quality System
- Schedule equipment calibration and maintenance in eQMS system.
- Develop and maintain working relationship with external service providers
- Provide technical support to the Quality Control Inspectors as needed
- Review and approve equipment calibration and Planned Maintenance records
- Review validation protocols, and reports in support of equipment and process validation activity
- Assist in identifying, processing, and investigating non-conforming equipment
- Complete, maintain and distribute appropriate Quality records and documentation.
- Collaborate with Manufacturing Engineers, Product Development Engineers, Material Control Supervisors, Operations Supervisors, and Quality Engineers on projects
- Participate in external audits/inspections.
- Apply Quality Systems knowledge to execute project assignments.
Benefits/Perks:
- 401k
- Health Insurance
Please apply here directly if interested but If you are genuinely not interested, is there someone you can recommend?
