• Support product development as an embedded program team member working alongside program managers, researchers, human factors engineers, designers, mechanical engineers, electrical engineers and process engineers.
• Lead program managers and engineers for the identification of suppliers to support concept and late-stage development prototype builds.
• Qualify suppliers via capability questionnaires, risk assessment, supplier file creation/management and on-site audits.
• Represent program teams for collaboration with corporate procurement and supply chain resources.
• Collaborate with finance team to setup suppliers in corporate purchase request and purchase order systems.
• Develop incoming inspection plans for concept and late-stage development build materials based on input from program managers, engineers and suppliers.
• Plan and support test method and process validation activities completed by suppliers.
• Complete incoming inspection and management of materials for controlled development builds.
• Manage site non-conforming material review process.
• Lead supplier-related corrective action and preventive action resolution.
• Participate in activities pertaining to cycle time and process improvements.
• Manage site quality management system approved supplier list, supplier files and supplier performance metrics for service and material suppliers.
• Establish, evaluate, qualify, encourage use of and continuous improvement to supplier management processes, procedures and standard tools used by program teams.
• Participate in internal, customer and notified body audits of the quality management system.
• Interacts with customers, suppliers and external auditors to develop close working relationships.
• Participates in customer strategy meetings and discussions regarding the development of program quality requirements and plans.
• Participates in the technical review process on development programs.

• 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).

Join Our Team