Zoll Medical Corporation
Principal Supplier Quality Engineer
Zoll Medical Corporation, San Jose, California, United States, 95199
At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions.
The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL!
Job Summary Support activities relating to the management of ZOLL Supplier Quality Engineering program. Assist the Procurement, Quality Assurance and Manufacturing departments with the day to day issues relating to supplier Certification, Verification, and/or Quality. Assess suppliers' performance and drive continuous process & yield improvement projects throughout ZOLL Supplier base. May have direct reports. Travel may be required.
Essential Functions
Support, collaborate, and work on; New Product Introductions, Cost Reductions, and part resourcing activities through the completion of supplier Verification and Validation of ZOLL designed parts/assemblies.
Assist, collaborate and/or develop validation plans and reports to support outsourcing and supplier process changes.
Collect, review, and summarize validation objective evidence.
Issue supplier SCARs/CAPAs as appropriate.
Support the R&D, Component and Purchasing organizations with the identification, assessment and qualification of new vendors.
Manage assigned suppliers or commodities through the review of supplier performance data, communication of supplier performance with supplier, driving improvements in supplier's delivered quality, review and validation of supplier proposed changes.
Develop suppliers driving improvements for the benefit of ZOLL.
Conduct periodic assessment, surveillance and improvement audits at existing suppliers.
Perform certification audits on potential new suppliers.
May mentor, train, 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 or lead a team to conduct internal and supplier investigations for identified nonconformance's to root cause and support determination and implementation of corrective and preventative action.
Required/Preferred Education and Experience
Bachelor's Degree in engineering or other technical discipline required.
10+ years in a Supplier Quality Engineering role in Medical Device, or electronics, or electro-mechanical assembly and test environment required.
5 years’ experience auditing supplier quality management systems and manufacturing process for continuous improvement of suppliers required.
5 years’ experience with FDA QSR quality systems FDA 21CFR Part 820 and ISO 13485 required.
Knowledge, Skills and Abilities
ASQ CQA, or CQE certification required.
Strong knowledge of one or more manufacturing process (PCB fabrication & 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, 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 that operates in more than 140 countries around the world. 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 - $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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The Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Products include AEDs, trauma kits, ventilators, temperature management solutions, and more. Our dedicated employees take pride in their commitment to improving patient outcomes while delivering world-class customer service.
At ZOLL, you won’t just have a job. You'll have a career—and a purpose. Join our team. It’s a great time to be a part of ZOLL!
Job Summary Support activities relating to the management of ZOLL Supplier Quality Engineering program. Assist the Procurement, Quality Assurance and Manufacturing departments with the day to day issues relating to supplier Certification, Verification, and/or Quality. Assess suppliers' performance and drive continuous process & yield improvement projects throughout ZOLL Supplier base. May have direct reports. Travel may be required.
Essential Functions
Support, collaborate, and work on; New Product Introductions, Cost Reductions, and part resourcing activities through the completion of supplier Verification and Validation of ZOLL designed parts/assemblies.
Assist, collaborate and/or develop validation plans and reports to support outsourcing and supplier process changes.
Collect, review, and summarize validation objective evidence.
Issue supplier SCARs/CAPAs as appropriate.
Support the R&D, Component and Purchasing organizations with the identification, assessment and qualification of new vendors.
Manage assigned suppliers or commodities through the review of supplier performance data, communication of supplier performance with supplier, driving improvements in supplier's delivered quality, review and validation of supplier proposed changes.
Develop suppliers driving improvements for the benefit of ZOLL.
Conduct periodic assessment, surveillance and improvement audits at existing suppliers.
Perform certification audits on potential new suppliers.
May mentor, train, 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 or lead a team to conduct internal and supplier investigations for identified nonconformance's to root cause and support determination and implementation of corrective and preventative action.
Required/Preferred Education and Experience
Bachelor's Degree in engineering or other technical discipline required.
10+ years in a Supplier Quality Engineering role in Medical Device, or electronics, or electro-mechanical assembly and test environment required.
5 years’ experience auditing supplier quality management systems and manufacturing process for continuous improvement of suppliers required.
5 years’ experience with FDA QSR quality systems FDA 21CFR Part 820 and ISO 13485 required.
Knowledge, Skills and Abilities
ASQ CQA, or CQE certification required.
Strong knowledge of one or more manufacturing process (PCB fabrication & 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, 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 that operates in more than 140 countries around the world. 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 - $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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