Insulet Corporation
Senior Supplier Quality Engineer (Onsite - Acton, MA)
Insulet Corporation, Acton, Massachusetts, us, 01720
Overview
Senior Supplier Quality Engineer (Onsite - Acton, MA)
role at Insulet Corporation. The Sr. Supplier Quality Engineer plays a key role in ensuring that materials, components, and services provided by suppliers meet Insulet’s quality and regulatory standards for medical devices. This individual will lead a team of Supplier Quality Engineers focused on driving Electronics commodity excellence. This position works closely with external suppliers in collaboration with internal cross-functional teams, including Supplier Development, R&D, Mfg. Engineering, Procurement, Regulatory Affairs, and Operations. Other significant impacts include collaborating on the selection and qualification of capable suppliers, leading efforts to quantify and improve supplier performance, and delivering a positive impact on product quality across a global footprint.
Responsibilities
Inspire and lead a team of Supplier Quality Engineers for day-to-day quality issues. Coach and mentor team members on supplier-related and internal Quality System issues. Engage in selection and evaluation activities of new potential suppliers, auditing first-tier and critical sub-tier suppliers for onsite quality, capability, technology and/or process-related requirements. Partner with suppliers and internal teams to ensure raw materials and components meet specifications and quality requirements. Communicate design and inspection changes to suppliers, ensuring alignment with internal procedures. Evaluate supplier inspection processes, provide recommendations and validate supplier’s ability to determine part acceptance. Lead and support supplier-driven quality improvement initiatives. Develop, maintain, and update supplier quality documentation and systems. Monitor supplier performance using scorecards and metrics (e.g., CAPA, audits, certifications, FMEAs). Issue and drive Supplier Corrective Action Report (SCAR); participate in root cause analysis of supplier-caused non-conforming product; drive corrective action and continuous improvement activities that impact performance for assigned suppliers. Support remediation efforts for suppliers with low quality performance and resolve issues related to nonconforming materials or services. Lead monthly quality performance reviews with high-defect suppliers to drive defect reduction and report progress. Manage supplier quality-related risks; develop and implement risk mitigation strategies; serve as escalation point for critical supplier quality issues. Manage Supplier Change Notification process for supplier quality related activities. Maintain accurate supplier records in ERP and PLM systems. Participate in internal and external audits, including root cause analysis and CAPA implementation. Review and approve material/component documentation and qualification protocols. Perform other duties as assigned.
Qualifications
Bachelor’s degree in Electronics / Electrical / Biomedical Engineering or equivalent education/experience. Solid knowledge in problem solving related to manufacturing processes of PCBAs, PCBs, and electronic sub-assemblies; strong understanding of SMT, ICT, FCT, and reliability testing. 5–8 years of experience in Quality Assurance within FDA, ISO, or other regulated environments. Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971. Familiarity with global regulatory requirements.
Preferred Skills
Ability to analyze supplier performance data and present actionable insights to drive improvement. Excellent time management and ability to multi-task and manage project milestones. Working knowledge of EN 60601 and ISO 62304. Certifications such as ASQ CQE, Six Sigma, or Lead Auditor (ISO 13485) are a plus. Strong communication skills and ability to work across multiple levels of the organization. Comfortable managing priorities in a dynamic, high-energy environment.
Additional Information
This position is based at the Acton, MA site. Estimated travel: 10-15%, with flexibility based on business needs. Expect 5–10% overlap with global manufacturing sites across various time zones.
Note: This position requires on-site working. The US base salary range for this full-time position is $84,900.00 - $127,350.00. Salary ranges are determined by role, level, and location. The range reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Individual pay is based on work location and other factors, including skills, experience, and education. Your Talent Acquisition Specialist can share more during the hiring process. This posting reflects base salary and does not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. For more information, please visit insulet.com and omnipod.com.
We are an equal opportunity employer. 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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Senior Supplier Quality Engineer (Onsite - Acton, MA)
role at Insulet Corporation. The Sr. Supplier Quality Engineer plays a key role in ensuring that materials, components, and services provided by suppliers meet Insulet’s quality and regulatory standards for medical devices. This individual will lead a team of Supplier Quality Engineers focused on driving Electronics commodity excellence. This position works closely with external suppliers in collaboration with internal cross-functional teams, including Supplier Development, R&D, Mfg. Engineering, Procurement, Regulatory Affairs, and Operations. Other significant impacts include collaborating on the selection and qualification of capable suppliers, leading efforts to quantify and improve supplier performance, and delivering a positive impact on product quality across a global footprint.
Responsibilities
Inspire and lead a team of Supplier Quality Engineers for day-to-day quality issues. Coach and mentor team members on supplier-related and internal Quality System issues. Engage in selection and evaluation activities of new potential suppliers, auditing first-tier and critical sub-tier suppliers for onsite quality, capability, technology and/or process-related requirements. Partner with suppliers and internal teams to ensure raw materials and components meet specifications and quality requirements. Communicate design and inspection changes to suppliers, ensuring alignment with internal procedures. Evaluate supplier inspection processes, provide recommendations and validate supplier’s ability to determine part acceptance. Lead and support supplier-driven quality improvement initiatives. Develop, maintain, and update supplier quality documentation and systems. Monitor supplier performance using scorecards and metrics (e.g., CAPA, audits, certifications, FMEAs). Issue and drive Supplier Corrective Action Report (SCAR); participate in root cause analysis of supplier-caused non-conforming product; drive corrective action and continuous improvement activities that impact performance for assigned suppliers. Support remediation efforts for suppliers with low quality performance and resolve issues related to nonconforming materials or services. Lead monthly quality performance reviews with high-defect suppliers to drive defect reduction and report progress. Manage supplier quality-related risks; develop and implement risk mitigation strategies; serve as escalation point for critical supplier quality issues. Manage Supplier Change Notification process for supplier quality related activities. Maintain accurate supplier records in ERP and PLM systems. Participate in internal and external audits, including root cause analysis and CAPA implementation. Review and approve material/component documentation and qualification protocols. Perform other duties as assigned.
Qualifications
Bachelor’s degree in Electronics / Electrical / Biomedical Engineering or equivalent education/experience. Solid knowledge in problem solving related to manufacturing processes of PCBAs, PCBs, and electronic sub-assemblies; strong understanding of SMT, ICT, FCT, and reliability testing. 5–8 years of experience in Quality Assurance within FDA, ISO, or other regulated environments. Solid understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971. Familiarity with global regulatory requirements.
Preferred Skills
Ability to analyze supplier performance data and present actionable insights to drive improvement. Excellent time management and ability to multi-task and manage project milestones. Working knowledge of EN 60601 and ISO 62304. Certifications such as ASQ CQE, Six Sigma, or Lead Auditor (ISO 13485) are a plus. Strong communication skills and ability to work across multiple levels of the organization. Comfortable managing priorities in a dynamic, high-energy environment.
Additional Information
This position is based at the Acton, MA site. Estimated travel: 10-15%, with flexibility based on business needs. Expect 5–10% overlap with global manufacturing sites across various time zones.
Note: This position requires on-site working. The US base salary range for this full-time position is $84,900.00 - $127,350.00. Salary ranges are determined by role, level, and location. The range reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Individual pay is based on work location and other factors, including skills, experience, and education. Your Talent Acquisition Specialist can share more during the hiring process. This posting reflects base salary and does not include bonus, equity, or benefits.
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. For more information, please visit insulet.com and omnipod.com.
We are an equal opportunity employer. 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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