Sr. Supplier Quality Engineer ; Manufacturing

Sr. Supplier Quality Engineer – I

Responsibilities

• Conduct and oversee supplier audits, qualification of new suppliers, and monitor performance of current suppliers.
• Provide quality guidance and support for supplier management activities such as qualifications, change notifications, audits, evaluations and performance to assure conformance to established standards, specifications and risk reduction.
• Optimize and continuously improve supplier operations to meet department, business unit and company objectives.
• Provide suggestions, guidance and feedback to suppliers to ensure quality materials and components are delivered for use in Tandem’s product operations.
• Manage, lead and/or oversee supplier audits to meet company, quality, and regulatory requirements, including country‑specific requirements; responsibilities extend to audits performed by 3rd‑party contractors.
• Generate, approve, review and monitor Supplier CAPA plans and activities to investigate and close out, with objective evidence of verification of effectiveness.
• Partner with Quality, process owners, legal and suppliers to create and revise Quality Agreements as needed.
• Qualify, manage, and monitor supplier performance per Tandem supplier management approved processes.
• Identify gaps in current processes and develop and document new processes as needed.
• Lead, develop, communicate and implement strategies for continuous improvement and development of existing or new suppliers and contract manufacturers.
• Build relationships and work with suppliers or contract manufacturers to establish and maintain controlled consistent manufacturing processes and methods suitable to the nature of the supplied components or assembly parts.
• Independently lead and complete supplier activities such as supplier evaluations, change notifications, and validations.
• Facilitate quality oversight of Tandem’s 3rd‑party contract manufacturers.
• Provide guidance to suppliers or contract manufacturers on quality engineering disciplines and statistics (e.g., PFMECA, DMAIC, Lean, Problem‑Solving tools, capability analysis, DOE, IQ/OQ/PQ validations).
• Report quality trends and information to management on the performance of suppliers or contract manufacturers.
• Follow up with suppliers for component‑related non‑conformances identified during incoming inspection, in‑process inspection, final test, quality complaints, and product returns.

• Hybrid: role performed at Barnes Canyon facility in San Diego, CA, with remote work. Expected in‑office 2–3 days per week, may vary.

• Direct experience with suppliers and contract manufacturers producing components or assembly parts in a regulatory environment.
• Proficient knowledge of Quality Engineering policies, principles and best practices including ISO
  13485, ISO
  14971, ISO
  9001 and other appropriate industry standards.
• Competent in QMS Audit and Process Audit practices with ability to readily recognize non‑conformances and explain audit results.
• Strong knowledge and application of Good Manufacturing Processes (GMP).
• Proficiency in statistical techniques: sampling theory, probability, capability, and SPC.
• Proficiency in problem‑solving methodologies: 5‑why analysis, fault‑tree analysis, cause‑and‑effect diagram, etc.
• Ability to work independently to identify potential quality issues and implement solutions.
• Understanding of mechanical drawings & specifications including GD&T.
• Able to assert own ideas and persuade others through effective consolidation, evaluation, and presentation of relevant information.

• Bachelor’s degree in Engineering (electro‑mechanical or equivalent) or equivalent education and applicable work experience.
• ISO Lead Auditor, Certified Quality Engineer, or equivalent preferred.
• Minimum 5 years related experience in Supplier Quality or related engineering positions.
• Familiarity with production of PCB, PCBA, electro‑mechanical assemblies and plastic molding highly desirable.
• Medical device manufacturing or FDA‑regulated industry experience highly preferred.
• Supplier or lead quality auditing experience in a regulated company highly preferred.
• Experience managing 3rd‑party contract…