Supplier Quality Manager

Mirion•Florham Park, NJ

126d

About The Position

The Supplier Quality Manager is a hands-on leader responsible for ensuring hardware and software products meet or exceed the quality expectations and requirements of internal and external customers. The role covers quality assurance for products in development, quality control and assurance in manufacturing and product changes, and supplier quality management. The manager supports inspections and works with department leaders to maintain compliance and inspection readiness. They also help trend and report quality data and coordinate communication with leaders throughout the organization.

Requirements

Bachelor of Science degree in Engineering or a related technical field.
5–10+ years of hands-on experience in product quality management.
Working knowledge and experience with quality tools such as Statistical Process Control, LEAN, 5 Whys, Pareto, 8-D, and VOC.
Proficiency with DFx, DFMEA/PFMEA, DOE, benchmarking, and best-practice principles.
Familiarity with relevant standards and guidelines such as IPC-A-600/610, ISO 13485, and FDA 21 CFR 820.
Working experience with supplier qualification, supplier management, and supplier conflict resolution.
Excellent verbal and written communication skills.
Highly organized and attentive to detail.

Nice To Haves

Master’s degree preferred.
Product design and/or manufacturing experience desired.
Medical device industry experience highly desired.
Professional certification from the American Society for Quality (ASQ) preferred.
Experience with software and hardware products highly preferred.

Responsibilities

Plan, develop, and implement strategies and tactics that support corporate objectives and build an effective quality culture.
Ensure quality processes, practices, and inputs are incorporated throughout the product life cycle.
Develop quality metrics and KPIs, establish countermeasures when targets are not met, and 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 supplier performance and the quality of supplied materials and components.
Establish feedback loops so supplier knowledge can inform product designs.
Incorporate quality into supplier management and champion resolution of supplier quality issues.
Monitor, review, and correct adverse quality trends in the field, manufacturing, and test processes.
Monitor field failure rates and ensure feedback reaches engineering, support, and service teams.
Establish quality control processes and metrics for incoming, in-process, and final inspections of materials and products.
Promote enablement, engagement, and ownership in manufacturing to continuously improve product quality.
Represent Quality on new product development project teams.
Incorporate Design for Quality and effective quality assurance methods into new product introduction.
Manage pre- and post-release defect metrics and defect resolution throughout the product life cycle.
Ensure documentation complies with ISO/FDA and product life-cycle requirements.
Serve as the point of contact for product quality issues and related decisions.
Lead, mentor, and train team members.
Plan resources in response to strategic initiatives, workload trends, and changing quality and regulatory needs.
Foster collaboration and teamwork to create and share ideas, concepts, and processes.
Support inspections and work with department leaders to maintain compliance and inspection readiness.
Assist with quality data trending and reporting and communicate with leaders across the organization.