Sr Supplier Qual Engineer - Exempt

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. You will partner 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 a PhD with 0 years relevant experience.

Work Schedule:

This is a full-time position requiring 40 hours per week.

Location:

This position is onsite at our Louisville, CO site. Louisville offers a vibrant community with a beautiful landscape, excellent amenities, and a high quality of life, making it an ideal place to work and live.

Responsibilities:

Responsibilities may include the following and other duties may be assigned:

• Ensure that suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards and administer a Certified Supplier Program in receiving inspection to ensure cost-effectiveness.
• Monitor parts from acquisition through the manufacturing cycle and resolve supplier-related problems as they occur.
• Develop and prioritize an auditing schedule to ensure that designated suppliers are audited regularly to meet good manufacturing practices (GMP) and quality standards.
• Evaluate suppliers' internal functions to assess their overall performance and provide feedback on their operation.
• Provide Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with Component Engineering and Post-Market Supplier Quality Teams.
• Collaborate 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 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 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.

Differentiating Factors:

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower-level specialists; may manage projects/processes.
• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of workgroup objectives, through building relationships and consensus to reach agreements on assignments.
• Innovation and Complexity: Problems and issues faced are difficult and may require understanding of multiple issues, job areas, or specialties. Makes improvements of processes, systems, or products to enhance performance of the job area. Analysis provided is in-depth in nature and often provides recommendations on process improvements.
• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchanges information of facts, statuses, ideas, and issues to achieve objectives and influence decision-making.
• Leadership and Talent Management: May provide guidance, coaching, and training to other employees within the job area. May manage projects, requiring delegation of work and review of others' work product.