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SeniorFull-timeGit
Salary Range
$132,600 - $179,400 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are looking for a Supplier Quality Engineer to join our medical device company in Pleasanton, California. This role involves managing and maintaining the supply base, executing supplier process validations, and driving supplier performance to support Calyxo’s manufacturing and product development objectives.
Key Responsibilities
- →Serve as the primary quality and technical interface between Calyxo and the supply chain.
- →Perform supplier evaluations, selection, and maintenance activities.
- →Conduct supplier audits and issue reports detailing findings.
- →Drive and oversee process validation and part manufacturing qualification activities.
- →Execute and monitor progress toward supplier goals and objectives.
- →Maintain and control supplier files and records.
- →Monitor and report on supplier performance and work with suppliers on quality issues.
- →Review and analyze production data to determine factors affecting product quality.
- →Lead corrective and preventive actions related to supplier audit findings.
- →Assist in the development and maintenance of material specifications and quality assurance procedures.
- →Foster effective cross-functional relationships with suppliers and internal departments.
- →Serve as Subject Matter Expert during internal and external audits.
Requirements
- ✓Bachelor of Science in Engineering or Life Science discipline.
- ✓Minimum 8 years experience in Quality Assurance; minimum 5 years experience in Supplier Management.
- ✓Knowledge of applicable quality system requirements and standards such as FDA, QSR, ISO 13485, ISO 9001, and GHTF Guidance.
- ✓Experience with manufacturing processes such as electrical, mechanical, packaging, sterilization, injection molding, extrusion, etc.
- ✓Excellent organizational skills and ability to work on multiple projects simultaneously.
- ✓Strong analytical skills, problem-solving technique, and statistical application experience.
- ✓Strong written, oral, and interpersonal skills.
- ✓Compliance with relevant county, state, and Federal rules regarding vaccinations.
Benefits
- ★Competitive base salary range of $155,000 - $163,000 and variable incentive plan
- ★Stock options
- ★Employee benefits package that includes 401(k), healthcare insurance, and paid vacation
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