Job Description:

Description

The Product 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.

Key Areas of Responsibility:

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

Product Development and Product Change

• 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 SNC's Product Life Cycle Requirement

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

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

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 & Abilities:

• BS in Engineering or related technical discipline. MS preferred


• Product design and/or manufacturing experience desired, experience in medical device industry desired


• Professional certification from the American Society for Quality (ASQ) desired


• 5+ years of hands-on experience in product quality management, experience with SW and HW products desired


• Working 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


• Familiar with relevant standards & guidelines such as IPC-A-600/610, ISO 13485, and FDA21 CFR 820 desired


• Working experience with supplier qualification, supplier management, and supplier conflict resolution

Qualifications

EducationMasters of Engineering (preferred)
Bachelors of Engineering (required)
ExperienceWorking experience withquality tools such asStatistical Process Control, LEAN,5 Whys, Pareto, 8-D, VOC (required)
Proficient in using DFx, DFMEA/PFMEA, DOE, Benchmarking, and best practice principles (required)



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