Supplier Quality Engineer

Flex•Hollis, NH

About The Position

Flex is the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary. Job Summary Summary: The “Supplier Quality Engineer” will be based in Hollis, NH, reporting to Quality Manager. Responsible for supplier development in a manufacturing or service process; works with suppliers to continuously improve performance, implement process controls and develop quality assurance plans. What a typical day looks like: Facilitate selection of suppliers to support late-stage development and clinical builds. Qualify suppliers via capability questionnaires, risk assessment, supplier file creation/management and remote or on-site audits. Represent program team supplier quality requirements during collaboration with procurement and supply chain resources. Develop program supplier and incoming inspection plans for late-stage development and clinical builds based on input from program managers, engineers, suppliers and customers. Plan and support test method and process validation activities completed by suppliers. Complete incoming inspection and management of materials for late-stage development and clinical builds. Manage site non-conforming material review process. Lead supplier-related corrective action and preventive action resolution. Manage site quality management system approved supplier list, supplier files and supplier performance metrics. Participate in internal, customer and notified body audits of the quality management system. What we are looking to add to the team: Bachelor’s Degree in engineering, science, or equivalent technical discipline 4+ years of experience working in medical device product development Experience with ISO 13485, ISO 14971 & FDA 21 CFR 820 Analytical thinking, plus verbal and technical writing skills Demonstrated team collaboration experience American Society for Quality (ASQ) Certified Supplier Quality Professional (CSQP) (Preferred) What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement

Requirements

Bachelor’s Degree in engineering, science, or equivalent technical discipline
4+ years of experience working in medical device product development
Experience with ISO 13485, ISO 14971 & FDA 21 CFR 820
Analytical thinking, plus verbal and technical writing skills
Demonstrated team collaboration experience

Nice To Haves

American Society for Quality (ASQ) Certified Supplier Quality Professional (CSQP) (Preferred)

Responsibilities

Facilitate selection of suppliers to support late-stage development and clinical builds.
Qualify suppliers via capability questionnaires, risk assessment, supplier file creation/management and remote or on-site audits.
Represent program team supplier quality requirements during collaboration with procurement and supply chain resources.
Develop program supplier and incoming inspection plans for late-stage development and clinical builds based on input from program managers, engineers, suppliers and customers.
Plan and support test method and process validation activities completed by suppliers.
Complete incoming inspection and management of materials for late-stage development and clinical builds.
Manage site non-conforming material review process.
Lead supplier-related corrective action and preventive action resolution.
Manage site quality management system approved supplier list, supplier files and supplier performance metrics.
Participate in internal, customer and notified body audits of the quality management system.