Overview
Product Quality Manager Jobs in Melbourne, Florida, USA at Sun Nuclear Corporation
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 FDA
21 CFR 820 desired
Working experience
with supplier qualification, supplier management, and supplier
conflict resolution
Title: Product Quality Manager
Company: Sun Nuclear Corporation
Location: Melbourne, Florida, USA
Category: Quality Assurance – QA/QC (Quality Control / Manager, Quality Engineering, Quality Technician/ Inspector, QA Specialist / Manager)
