Supplier Quality Manager

Key Areas Of Responsibilities

• Plan, develop, and implement strategies and tactics to support corporate objectives to build an effective quality culture.
• Ensure quality processes, practices and inputs are appropriately incorporated into entire product life cycle.
• Develop quality metrics and KPI’s to support corporate objectives and countermeasures when not met; analyze and report trends to site Operations management.
• Collaborate with procurement and strategic supplier management to establish supplier quality performance criteria.
• Monitor, review, and improve quality of supplier performance and supplied materials and components.
• Ensure the presence of a robust feedback loop that allows supplier’s knowledge to be incorporated in product designs.
• Incorporate quality into the supplier management process, and actively champion supplier quality issues resolutions.
• Monitor, review, and correct adverse trends in the field, in manufacturing, and test processes to meet quality goals.
• Monitor field failure rates and ensure an effective feedback process into engineering, support, and service teams.
• Quality control processes and metrics for incoming, in-process, and final inspection of materials and products.
• Foster enablement, engagement, and ownership in manufacturing to continuously improve product quality.
• Serve as a Quality Representative on all new product development project teams.
• Incorporate Design for Quality and effective quality assurance methods into the new product introduction process.
• Defect Management including pre- and post-release defect metrics and defect resolution through entire product life cycle.
• Documentation compliant to ISO/FDA and Product Life Cycle Requirement.
• Point of contact for any product quality related issues and decision making.
• Leadership, mentoring, and training of team members.
• Resource planning based on strategic initiatives, trends in work levels, and changing quality and regulatory needs.
• Foster collaboration and team work to create and share new ideas, concepts, and processes.

Knowledge, Skills And Abilities

• B.S. degree in Engineering or a related technical field. MS preferred.
• Product design and/or manufacturing experience desired, experience in medical device industry highly desired.
• Professional certification from the American Society for Quality (ASQ) preferred.
• 5-10+ years of hands-on experience in product quality management required and experience with SW and HW products highly preferred.
• Must have working knowledge and experience with quality tools such as Statistical Process Control, LEAN, 5 Whys, Pareto, 8-D, VOC.
• Proficient in using DFx, DFMEA/PFMEA, DOE, Benchmarking, and best practice principles necessary.
• Familiar with relevant standards & guidelines such as IPC-A-600/610, ISO 13485, and FDA21 CFR 820.
• Working experience with supplier qualification, supplier management, and supplier conflict resolution.
• Excellent communication skills (verbal and written); must be highly organized and attentive to detail.