Sr Supplier Quality Engineer

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

• Ensures that suppliers deliver quality parts, materials, and services.
• Leads cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection.
• Lead and/or participate in corrective/preventive action teams in resolving supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).
• Coaches team members on supplier quality principles, quality system requirements, statistical analysis, and application of technical analysis to daily assignments.
• Define component qualification strategy (PPAP), partner with suppliers to develop qualification plan, report performance, and demonstrate release readiness. Author or review key component engineering lifecycle deliverables throughout product development, as defined by procedures. Define control plans to ensure appropriate acceptance activities.
• 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.
• Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
• Provides technical guidance and quality compliance for Supplier Quality engagement throughout the product’s lifecycle. Including implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Develops and delivers the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for existing products.
• Define Receiving Inspection requirements as required and associated test method validation for internal clients Test Methods.
• Evaluates and acts as a lead in processing and approving supplier change requests.
• Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
• Supports internal and external audit and inspections, including preparation and resolution of audit and inspection findings
• Collaborates cross-functional with internal stakeholders and interacts with multiple levels of personnel internally and externally to ensure timely completion and approvable output of Supplier CAPA records.
  
  

Top 3 technical skills that are required for the role:

Strong Background in Quality Systems related to Supplier Controls

Proven Excellence in Problem Solving - DMAIC, CAPA, or similar

Experience in SAP, Agile, and Track Wise (Nice to Have)

TECHNICAL SKILLS ~Must Have

Advanced Supplier Development

CAPA

DMAIC

ISO 13485

Medical Device

Minitab

• Experience working with Injection Molding Suppliers
  
  

Education Required: Bachelor's Degree and 4 years of relevant experience OR advanced 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.

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 indepth 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 University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.