Sr Supplier Qual Engineer - Exempt

Job Description

Job Description

The Senior Supplier Quality Engineer plays a critical role in ensuring product quality, safety, and regulatory compliance throughout the medical device product lifecycle, with a primary focus on product design, development, and sustaining engineering. As the supplier quality representative on cross-functional project teams, you will provide technical leadership in supplier controls, risk management, verification and validation, and quality system compliance, partnering closely with Research & Development, Manufacturing, Regulatory Affairs, and Supply Chain to deliver safe, effective, and compliant medical technologies.

Top 3 Technical Skills Required for the Role:

• 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.

Education and Experience Required:

Requires a Baccalaureate degree and a minimum of 4 years of relevant experience OR a Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.

Work Schedule and Location:

The contractor will be working 40 hours a week. This position requires the candidate to be onsite at the Louisville, CO site.

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 the company 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 test methods.

Technical Specialist Career Stream:

An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.

Location Pitch:

Join us in Louisville, CO, a vibrant community nestled against the backdrop of the stunning Rocky Mountains. Enjoy a high quality of life with access to outdoor activities, a thriving local culture, and a welcoming community atmosphere.