Sr Supplier Qual Engineer – Exempt

Planet Pharma; Louisville (CO); On-site; USD 110,000 - 140,000; Full time

Job summary

Medtronic is seeking a Senior Supplier Quality Engineer to ensure quality, safety, and regulatory compliance across the medical device lifecycle. You will lead supplier controls, risk management, and quality system activities while partnering with R&D, Manufacturing, and Regulatory affairs.

The role emphasizes cross‑functional leadership, supplier qualification, and continuous improvement to deliver compliant, high‑quality components and devices.

Qualifications

• Bachelors with 4+ years relevant experience or Masters with 2+ years relevant experience.
• Ability to lead cross-functional teams and drive quality decisions without direct authority.
• Experience qualifying suppliers and managing CAPA and nonconformances across NPD/PMO.

Responsibilities

• Qualify suppliers and manage receiving inspection where applicable.
• Monitor supplier performance and communicate issues to ensure GMP and quality standards.
• Lead audits and risk assessments of supplier components and processes.
• Provide QA guidance for Pre-Market and NPD activities in collaboration with engineering and regulatory teams.
• Support the Product Acceptance Sampling Strategy and Approved Supplier List processes.

Skills

New product development support

Cross-functional leadership

Supplier changes & CAPA

Education

Bachelor’s degree + 4+ years

Master’s degree + 2+ years

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 technicalskills that are required for the role:

• 1.Experience supportingnew product development (NPD) or design transfer to suppliers.
• 2.Strong analytical, collaboration, communication, and influencing skills, with the ability to lead cross-functional teams and drive quality decisions without direct authority.
• 3.Partner with cross-functional teams to support supplier changes, nonconformances, and CAPA activities.

Education Required/Years’ Experience Required:Requires a Baccalaureate degreeAND minimum of 4 years of relevant experience OR Master’s degree with a minimum of 2 years relevant experience

Responsibilities may include the following and other duties may be assigned. 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. Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: 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 Medtronic 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 Medtronic 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 others 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 work group 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.Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decision-making.

Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.May manage projects, requiring delegation of work and review of others’ work product.

Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience.May have practical knowledge of project management.Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.