The Supplier Quality Manager is a hands-on leader, responsible for ensuring that all products, including Hardware and Software, meet or exceed the quality expectation and requirements of external and internal customers. This includes quality assurance of products in development, quality control and assurance of product manufacturing and product changes, as well as management of supplier quality. This individual will play a key role during inspections and will work with department leaders to remain in compliance and inspection ready at all times. This role they will assist in the trending and reporting of quality data and will interface with leaders throughout the organization to drive proper communication.

KEY AREAS OF RESPONSIBILITIES:

Quality Culture

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.

Supplier Quality

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 .

Production Quality

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.

Product Development and Product Change

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.

Team Leadership:

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

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