Position Overview: The Supplier Quality Engineer - Medical Device will be responsible for ensuring the quality of materials and components received from suppliers for use in the production of medical devices. This role will involve working closely with suppliers to implement quality improvement initiatives and ensure compliance with industry standards.
Key Responsibilities:
Implement and maintain an effective supplier quality management system, including auditing processes and procedures.
Conduct supplier audits to assess their quality systems and capabilities, and work with suppliers to address any issues.
Review and approve supplier documentation, including APQP, PPAP, SPC, and GD&T.
Monitor supplier performance and implement corrective actions as needed.
Lead root cause analysis and corrective action processes for supplier-related quality issues.
Collaborate with cross-functional teams to identify and resolve quality issues related to suppliers.
Ensure that suppliers are compliant with industry standards, such as ISO 13485.
Utilize lean principles to continuously improve supplier quality and efficiency.
Maintain accurate records of supplier quality performance and communicate updates to relevant stakeholders.
Qualifications:
Bachelor's Degree in Engineering or related field.
Minimum of 3 years of experience in a quality engineering role in the medical device industry.
Strong knowledge of industry standards, including ISO 13485, supplier audits, QMS
Knowledge of APQP, PPAP, SPC, GD&T, and other quality tools.
Familiarity with lean principles and continuous improvement methodologies.
Experience with corrective action processes, such as SCAR and DMAIC, is preferred
Benefits
Vacation/PTO
Medical
Dental
Vision
401k
Applicants must be authorized to work in the U.S.
Kylie Mullins is recruiting for this position and the positions below.
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Employees will receive paid leave to the extent required by state or local law. This job was first posted by CyberCoders on 06/27/2024 and applications will be accepted on an ongoing basis until the position is filled or closed.
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, age, sexual orientation, gender identity or expression, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, status as a crime victim, disability, protected veteran status, or any other characteristic protected by law. CyberCoders will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable state and local law, including but not limited to the Los Angeles County Fair Chance Ordinance, the San Francisco Fair Chance Ordinance, and the California Fair Chance Act. CyberCoders is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please contact a member of our Human Resources team to make arrangements.
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