SUMMARY

As the Supplier Quality Engineer, you will report to the Supplier Quality Manager and partner with cross-functional teams to execute critical Supplier Quality activities throughout the product development lifecycle. You will ensure that your work meets the highest quality standards and complies with all applicable compliance standards and regulations. This is a hands-on role requiring experience in supplier management, risk management, manufacturing line bring ups, and design transfer. As a Supplier Quality Engineer, you will directly support the development of scalable quality systems by executing vital quality engineering activities across multiple programs.

PRIMARY ROLE AND RESPONSIBILITIES

• Support the selection, evaluation and monitoring of suppliers and assist in maintaining the Approved Supplier List (ASL)
• Work with suppliers and the Supplier Quality Manager to ensure quality agreement and technical expectations are met
• Identify supplier risks and work with cross-functional teams to prevent and/or resolve issues which could interrupt business continuity
• Assist in maintaining procedures to ensure that the organization complies with applicable regulatory standards
• Support suppliers and the technical team through key activities such as process FMEAs, manufacturing flow and control plans, master validation plans, process validation (IQ/OQ/PQ), and equipment qualifications
• Work with the Engineering and Operations teams to establish manufacturing test specifications, critical to quality specifications, and inspection criteria
• Execute Supplier Audits, Supplier Qualifications, Supplier Corrective Actions (SCARs), Supplier Change Assessments, Non-conformance Reports (NCRs)
• Participate and provide engineering input at Material Review Board (MRB) meetings
• Track and report on defined KPIs and metrics for Supplier Quality
• Support internal and external audits by coordinating and providing documentation and evidence of compliance
• Foster a collaborative environment, support continuous improvement initiatives, and promote a quality culture across the organization

QUALIFICATIONS

• Bachelor’s or Master’s degree in Engineering (e.g., Biomedical, Mechanical, Electrical, or related field).
• 3 – 7 years of quality engineering or in medical device development from concept development to production release.
• Strong understanding of medical device regulations and standards (FDA, ISO 13485, IEC 62304, ISO 14971, IEC 62366-1) and experience working in a regulated environment
• Ability to travel up to 25% of the time
• Prior experience in product / manufacturing line transfers
• Hands-on experience with risk management tools (e.g. FMEA, risk analysis)
• Experience in establishing work relationships across multi-disciplinary teams and with partners in different time zones, building trust and demonstrating critical thinking
• Experience in navigating ambiguity, bringing clarity to complex situations and thriving in a fast-paced environment

OTHER QUALIFICATIONS

• Proficient in working in eQMS tools with impeccable documentation skills
• Superior written and verbal communication skills to interface with cross-functional teams and regulatory bodies
• Strong analytical skills and excellent problem-solving skills
• Exceptional organizational skills and attention to detail