Principal Supplier Quality Engineer

4 weeks ago


San Jose, California, United States ZOLL Circulation Full time
Job Summary

Support the management of ZOLL's Supplier Quality Engineering program, collaborating with Procurement, Quality Assurance, and Manufacturing departments to resolve day-to-day issues related to supplier certification, verification, and quality.

Assess suppliers' performance and drive continuous process and yield improvement projects throughout the ZOLL supplier base. May have direct reports and require travel.

Key Responsibilities
  • Support new product introductions, cost reductions, and part resourcing activities through supplier verification and validation of ZOLL-designed parts and assemblies.
  • Assist in developing validation plans and reports to support outsourcing and supplier process changes.
  • Collect, review, and summarize validation objective evidence.
  • Issue supplier SCARs/CAPAs as necessary.
  • Manage assigned suppliers or commodities through the review of supplier performance data, communication of supplier performance, and driving improvements in supplier-delivered quality.
  • Develop suppliers to drive improvements for the benefit of ZOLL.
  • Conduct periodic assessment, surveillance, and improvement audits at existing suppliers.
  • Perform certification audits on potential new suppliers.
  • Mentor, train, and supervise one or more Supplier Quality Engineers.
  • Manage Supplier Quality support for issues arising at incoming inspections and production environments.
  • Work independently and as part of a team to conduct internal and supplier investigations for identified nonconformances to root cause and support determination and implementation of corrective and preventative action.
Requirements
  • Bachelor's Degree in engineering or other technical discipline required.
  • 10+ years in a Supplier Quality Engineering role in Medical Device, electronics, or electro-mechanical assembly and test environment required.
  • 5 years' experience auditing supplier quality management systems and manufacturing processes for continuous improvement of suppliers required.
  • 5 years' experience with FDA QSR quality systems and ISO 13485 required.
  • ASQ CQA or CQE certification required.
Preferred Qualifications
  • Strong knowledge of one or more manufacturing processes (PCB fabrication and assembly, injection molding, metal forming, catheter fabrication and assembly, box builds).
  • Strong background in supplier assessment and development in a medical device environment.
  • Development and execution of validation plans including IQ, OQ, and PO protocols utilizing various quality tools such as documentation review, process flow maps, control charts, and PFMEA.
  • Peer review of validation plans and reports to assure adequate technical and material quality rational.
  • Strong background in product structure, BOMs, Product Lifecycle Management Systems, and MRP systems.
  • Proficient in PC-based applications (Word, Excel, Access, PowerPoint, MS Project, etc.).
Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • Standing - Occasionally
  • Walking - Occasionally
  • Sitting - Frequently
  • Talking - Occasionally
  • Hearing - Occasionally
  • Repetitive Motions - Frequently

ZOLL is a fast-growing company operating in over 140 countries worldwide. Our employees are inspired by a commitment to make a difference in patients' lives, and our culture values innovation, self-motivation, and an entrepreneurial spirit.

Join us in our efforts to improve outcomes for underserved patients suffering from critical cardiopulmonary conditions and help save more lives.

The total compensation range for this position can range from $140,000 to $184,000. The actual compensation may vary outside of this range depending on geographic location, work experience, education, and skill level.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



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