Sr Supplier Qual Engineer - Exempt

A Day in the Life:

• Support and lead Supplier Quality activities per company requirements.
• Support and lead Product Qualification activities ensuring suppliers are capable of delivering quality products, materials, and services.
• Assess and qualify suppliers according to company requirements.
• Monitor products through the manufacturing cycle and resolve supplier-related problems before they occur.
• Provide technical guidance and quality compliance for Supplier Quality engagement throughout the Product lifecycle.
• Lead and develop the Product Acceptance Strategy for incoming inspection and associated test method validation for all internal test methods.
• Lead and support Supplier Change Requests.
• Lead Supplier Related Non-Conformance Material Reports (NCMRs) through disposition, corrective and preventative actions with Supplier.
• Assist in Approved Supplier List (ASL) Activities.
• Provide routine communication and updates to leadership regarding supplier activities and performance.

Top 3 things you are looking for in a candidate’s experience:

• Medical Device Experience
• Electrical / Mechanical background
• Component / Product Qualification – Including Test Method Validations, Equipment / Process Validations, strong understanding of process capability.

Education Required: Bachelors in Engineering.

Years’ Experience Required: 3-6 years.

Work Schedule: 40 hours per week, fully onsite.

Interview Timeline: Interviews can start as early as 21-Sep.

Product Line Support: Sphere-9 Catheter Production in Billerica, MA.

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.
• Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams.
• 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.

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. 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 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.

Location Highlight: Join us in Billerica, MA, a vibrant community known for its rich history and proximity to major innovation hubs. Experience a blend of small-town charm and easy access to the dynamic Greater Boston area.