1. Drives supplier qualification/approval process by assessing supplier QMS as well as manufacturing and technology capabilities through onsite and virtual audit activities
2. Supports design, development, and manufacturing operations toward resolution of supplier quality problems as well as the implementation of corrections and corrective actions
3. Works with suppliers to establish and maintain robust/rigorous measurement methodologies
4. Partners with suppliers to establish and maintain controlled manufacturing processes
5. Ability to collaborate externally with suppliers as well as internally with Quality, Operations, Supply Chain, Procurement and Engineering.
6. Performs root cause analysis and corrective actions for supplier quality issues (SCARs)
7. Performs supplier validation activities using Advanced Product Quality Planning (APQP)
8. Performs supplier Production Part Approval Process (PPAP) activities
9. Supports the reporting of supplier quality trends, performance, and other information to leadership
10. Travel up to 25% may be required
11. Support and subsequently implements assigned Quality Plans
12. Supports and if needed owns Corrective Action and Preventive Action (CAPA) projects and implements relative action items
13. Performs techniques for continuous improvement such as Lean, Six-Sigma, Poka-Yoke (Error Proofing), Measurement System Analysis and FMEA (Failure Mode and Effects Analysis)
14. Partners with suppliers to establish and maintain controlled manufacturing processes
15. Other duties and responsibilities as assigned.
16. Supports audit, Internal and External
17. Partners with suppliers to establish and maintain controlled on Supplier imposed changes

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com .

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Required Skills & Experience

1. Bachelor's degree in an engineering discipline is required
2. A minimum of 5 years total experience in a Quality or Supplier Quality engineering role is required. A minimum or 3 years in Supplier Quality role desired
3. Prior experience within a regulated industry (e.g., medical device, pharma, Automotive, Aerospace) is required
4. Lead Auditor certification is required
5. CAPA experience- Candidate must have worked and performed root cause analysis.
6. Design Controls- Candidate to have experience in working with Design Controls either in an NPI or Operations setting
7. Demonstrated knowledge of the Quality Engineering body of knowledge is required
8. Good communication and strong writing skills are required
9. Expertise with PCB, PCBA, or electro-mechanical assemblies is a plus.
10. ASQ certifications are a plus (CQE, CRE, CSQE, Six Sigma, CMDA, CQA)
11. Demonstrated knowledge of DMAICSix Sigma and problem-solving methodologies is a required
12. Candidate must be able to work autonomously and independently
13. Working knowledge of any of these standards desired: 21CFR part 820 (QSR), ISO13485, ISO/TR 24971:2020, IEC 60601-1, IEC 62304, IEC 623666-1, ISO 10993-1

Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.