Sr Supplier Qual Engineer

Sr Supplier Quality Engineer – Exempt

In this exciting role you will be responsible for the management of some of our strategic Contract Manufacturers (CMs) and Original Equipment Manufacturers (OEMs) within the Endoscopy and Cranial & Spinal Technologies businesses. You support changes to existing supplied products and processes, as well as oversee nonconformances related to these products. You partner with CMs, OEMs and sub‑tier suppliers to maintain necessary controls and use the Production Part Approval Process (PPAP) to guide qualification activities while working in conjunction with suppliers’ quality management systems.

You work in partnership with internal R&D, Quality, Regulatory, and Operations teams to ensure supplied products conform to finished device requirements and changes are qualified in a timely manner, keeping manufacturing lines running and providing customers with the highest quality and reliable products while staying compliant with applicable industry standards, regulatory requirements, and customer requirements.

Our Global Quality Strategy is rooted in the company Mission and Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.

• Endoscopy products (examples):
  The HET Bipolar Forceps, Beacon, and Barrx products
• Cranial & Spinal Technologies products (examples):
  The Aquamantys and AxiEM products

• Coordinate and monitor the change control process (including review and approval) to ensure performance, compliance and regulatory requirements are met and properly documented.
• Oversee changes to processes/products currently in production to aid in correcting process, design or material problems, including sub‑tier supplier and material changes.
• Review/prepare test plans and reports (qualification/validation) for supplier change requests and improvement activities using PPAP when required.
• Ensure resolution of all issues raised during testing/qualification.
• Support/Lead sustaining engineering projects such as manufacturing process transfers, label/IFU updates, sub‑tier supplier qualification, performance testing (verification/validation), and design qualification.
• Ensure suppliers deliver quality parts, materials and services.
• Monitor parts from acquisition through the manufacturing cycle and communicate and resolve supplier‑related problems as they occur.

• Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects, works with stakeholders to achieve desired results, may mentor colleagues or direct the work of lower level professionals.

• Autonomy:
  Works independently under limited supervision, determines solutions, coaches and reviews work of lower level specialists; may manage projects/processes.
• Organizational Impact:
  May be responsible for entire projects or processes within job area, contributing to the completion of work group objectives by building relationships and consensus.
• Innovation and Complexity:
  Confronts difficult problems, provides in‑depth analysis and recommendations for process improvements.
• Communication and Influence:
  Communicates with senior internal and external customers and vendors, influencing decision‑making.
• Leadership and Talent Management:
  Provides guidance, coaching and training to other employees; manages projects requiring delegation and review of others’ work.

• Advanced knowledge of the job area combining breadth and depth, typically from advanced education and experience.
• University degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

• 4+ years of Supplier Quality experience in the medical device industry or related field with supplier quality management experience.
• Experience supporting manufacturing processes including printed circuit board assembly, manual assembly, machining, injection molding, packaging, etc.
• Demonstrated working knowledge of supplier controls, process qualification (PPAP), nonconforming product controls, and protocol/report generation.
• Project Management experience.
• Working knowledge of statistical tools (Measurement System Analysis, Process Capability, Statistical Process Control, etc.).
• Strong oral and written communication skills.
• Ability to work in a team/partnership environment.
• Computer skills (Microsoft Word, Excel, Project, PowerPoint, Agile PLM systems).