Baccalaureate degree with 4+ years or Master's with 2+ years of relevant experience.
Experience in supporting new product development or design transfer to suppliers.
Strong analytical skills to assess supplier performance and compliance.
Excellent communication and influencing skills for cross-functional collaboration.
Ability to lead teams and drive quality decisions without direct management authority.
Responsibilities
Ensure suppliers deliver quality parts, materials, and services according to company standards.
Monitor parts from acquisition to manufacturing, resolving supplier-related issues as they arise.
Develop an auditing schedule for regular supplier audits to uphold good manufacturing practices.
Evaluate supplier performance and provide constructive feedback for improvement.
Support New Product Development by ensuring quality standards are met from the outset.
Provide technical guidance for Supplier Quality engagement throughout the product lifecycle.
Collaborate with Component Engineers to create and implement product acceptance strategies.
Benefits
Comprehensive health insurance options.
Retirement savings plan with company matching contributions.
Professional development and training opportunities.
Flexible work schedules to promote work-life balance.
Full Job Description
Roles and Responsibilities:
Ensures that suppliers deliver quality parts, materials, and services. Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Healthcare to provide customers with the highest quality and reliable products.
Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
Define Receiving Inspection requirements as required and associated test method validation for all internal Healthcare Test Methods.
Education and Experience:
Requires a Baccalaureate degree AND minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience.
Experience supporting new product development (NPD) or design transfer to suppliers.
Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority.
Partner with cross-functional teams to support supplier changes, nonconformances, and CAPA activities.
