Location: Concord, CA
Requirements: 5+ yrs Medical Device Quality Engineering, exposure to Electromechanical Medical Device equipment, Supplier Quality, ISO 13485
Headquartered in Northern California, we are a small and growing radiation medicine healthcare supplier with manufacturing operations in the US.
- Manage supplier evaluation and performance which includes managing supplier audit program
- Develop, revise, and maintain quality standards for supply chain
- Analyze and review product changes to ensure conformity with applicable regulations and company established specifications
- Manage the material change process (MRB)
- Develop QC and receiving inspection processes
- Approve quality records including reviewing and approving each device history record is complete
- Develop processes to ensure all manufacturing quality records are maintained
- Create SOPs and work instructions in accordance with all applicable quality and regulatory requirements
- Provide reports to management on the performance of the QMS against agreed KPIs, as well as make recommendations to ensure continuing effectiveness
- 5-10 years of related Quality Engineering
- Minimum 3 years of Medical Device industry experience (or similar highly regulated industry)
- Supplier Quality experience - developing relationships, evaluating performance, etc
- Background with Electromechanical Medical Device equipment
- Lead Auditor ISO 13485
- Bachelor's Degree in Engineering or related field
- Knowledge of Arena Solutions PLM & QMS Software
- Lean/Six Sigma black belt
Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.
Your Right to Work – In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.