Sr. Supplier Quality Engineer

Founded in 1976 and headquartered in Redmond, Washington, MicroSurgical Technology's passion is creating exceptional surgical devices and instruments used to restore or improve sight for patients all over the world. MST is part of UK based Halma PLC, a global company whose healthcare division helps provide technologies and solutions that enhance the quality of patients’ lives. Our products are surgeon-designed and meticulously crafted to instill confidence and assurance in Cataract and Glaucoma procedures and include a wide range of surgical instruments such as forceps, scissors, hooks, spatulas, and knives, all designed for the delicate and intricate procedures required in microsurgery. Together, we create a place where we are successful, motivated by our mission and inspire each other. This is where you can do your best work! Sr. Supplier Quality Engineer Hybrid – Redmond, WA Summary: The Sr. Supplier Quality Engineer (Sr. SQE) is responsible for ensuring the quality and compliance of purchased materials, components, and services from external suppliers in accordance with applicable regulatory requirements (e.g., FDA 21 CFR Part 820, ISO 13485, EU MDR) and internal standards. The ideal candidate brings a strong background in supplier quality engineering, combined with additional expertise in sourcing, to effectively qualify suppliers, manage risk, drive continuous improvement, and support cost-effective procurement strategies without compromising quality. Key Responsibilities: Serve as the primary quality liaison for all suppliers. Lead the identification, selection, risk classification, qualification, and ongoing performance management of suppliers, involving cross-functional stakeholders as necessary and to ensure compliance with quality, regulatory and internal requirements. Conduct on-site and remote supplier audits to evaluate quality systems, manufacturing processes, and regulatory compliance. Monitor KPIs for suppliers (e.g., DPPM, on-time delivery, NCRs, SCARs, cost savings, responsiveness, etc.) through reporting and proactively raising any emerging supplier quality/performance issues to appropriate levels of management and other stakeholders. Negotiate supplier terms/conditions, including pricing, lead times, incoterms, service levels, quality requirements, confidentiality/IP protection, etc. Ensure appropriate contracts (e.g. Supply Agreements and Quality Agreements) are established, maintained and enforced. Support incoming inspection optimization through receiving inspection (and sample) plan development and first article inspection (FAI) coordination. Evaluate supplier changes from a quality and regulatory perspective and lead the supplier change notification process. Provide supplier quality engineering and sourcing support for NPI and sustaining engineering projects involving supplier-provided components or processes, ensuring supplier readiness and sourcing alignment with project timelines. Support design transfer and commercialization by ensuring strategic supply continuity. Actively participate in MRB, leading the evaluation and disposition of nonconforming materials involving suppliers, as well as root cause analysis and VOE activities. Review and approve supplier-related validation/qualification activities, including PPAP, IQ/OQ/PQ, Gage R&R, and process capability analysis. Maintain supplier files and ensure accurate and current documentation, including quality agreements, certificates, audit reports, etc. Develop and implement strategic sourcing plans to support current and future product and operational needs. Take ownership of CAPAs related to the supplier management process. Participate in Quality & Management Reviews, driving overall strategy of the supplier management process and taking ownership of metrics & Quality Objectives related to supplier management. Support continuous improvement initiatives by identifying opportunities to enhance the QMS, particularly in areas related to supplier management. Support regulatory submissions and inspections by providing supplier quality documentation. Participate in internal and external audits as the SME for supplier management. Share technical expertise with others and develop/mentor other engineers. Performs other duties assigned as needed. Qualifications: Bachelor’s degree in Engineering, or related discipline. Minimum 5 years of experience in the medical device (or other heavily regulated) industry, with a strong focus on supplier management, quality, engineering and/or sourcing. ISO 13485 Lead Auditor certification or equivalent. Knowledge of FDA QSR/QMSR, MDSAP, EU MDD/MDR, ISO 13485, ISO 14971 and other relevant standards and regulations. Expertise in statistical analysis techniques and tools (e.g. Minitab, JMP, etc.). Experience in data visualization, detailed analytics, and interactive dashboards using software tools such as Power BI, MS Excel, etc., is highly desirable. Experience with process and test method validation (e.g., IQ, OQ, PQ, Gage R&R, etc.). Proficiency in quality planning tools such as APQP, PPAP/FAI, FMEA, MSA, Control Plans, and Control Charts. Excellent communication and interpersonal skills, with the ability to work effectively in a cross-functional team environment. Experience in working with contract manufacturers and suppliers involved in complex processes or the production of critical parts. Experience in contract negotiation, cost analysis, and supplier risk management. Strong analytical, problem-solving, and project management skills. Experience in leading discussions with external auditors. ASQ Certification (CQE, CRE, or similar) is highly desirable. Must be able to travel up to 25-50% domestic and international. Bilingual or multilingual proficiency (Mandarin, Vietnamese, Thai, Spanish, etc.) is highly desirable. Salary range: $110-145k The salary range listed in this posting reflects the compensation for a successful candidate in the assigned geographic territory. The successful candidate’s actual pay will be based on various factors such as skills, qualifications and experience. This role is eligible for a competitive benefits package that includes medical, dental, vision, life, and disability insurance; 401K retirement plan; flexible spending and health savings account; paid holidays; paid time off; parental leave; employee assistance program and other company benefits. MicroSurgical Technology Inc. is an equal opportunity employer and does not discriminate based on gender, sex, age, race and color, religion, marital status, national origin, disability, sexual orientation, gender identity or expressions, veteran status, or any other category that is protected by applicable law. Please note that only qualified candidates will be contacted for further consideration. No agencies or recruiters please.

Location: Redmond, WA, US

Posted Date: 6/19/2025