Sr. Supplier Quality Engineer I (Contract Manufacturing)

Tandem Diabetes Care•Ruth, CA

1d•$100,000 - $123,000•Hybrid

About The Position

The Sr. Supplier Quality Engineer I is responsible for conducting and overseeing supplier audits, qualifying new suppliers, and monitoring the performance of current suppliers. This role provides quality guidance and support for supplier management activities such as qualifications, change notifications, audits, evaluations, and performance monitoring to ensure conformance to established standards, specifications, and risk reduction. The position is instrumental in optimizing and continuously improving supplier operations to meet department, business unit, and company objectives. The engineer will provide suggestions, guidance, and feedback to suppliers to ensure quality materials and components are delivered for use in Tandem’s product operations.

Requirements

Direct experience with suppliers and contract manufacturers who produce components or assembly parts in a regulatory environment.
Proficient knowledge of Quality Engineering policies, principles, and best practices including quality standards: 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.
Must be able to explain audit results and influence other's understandings of audit observations in a culturally sensitive, tactful, and professional manner.
Strong knowledge and application of principles outlined in Good Manufacturing Processes (GMP).
Strong knowledge of and demonstrated experience using statistical techniques: sampling theory, probability, capability, and SPC.
Strong knowledge of and demonstrated experience using 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 geometric dimensioning and tolerances (GD&T).
Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.

Nice To Haves

Bachelor’s degree in Engineering, preferably Electro-Mechanical Engineering or the 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 in the production of PCB, PCBA, electro-mechanical assemblies and plastic molding is 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 in managing 3rd party contract manufacturers is a plus.

Responsibilities

Manage, lead, and/or oversee supplier audits to meet company, quality, and regulatory requirements, including country-specific requirements for the suppliers; responsibilities extend to audits performed by 3rd party contractors.
Generate, approve, review, and monitor Supplier CAPA plans and activities from investigation to closure, including 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 to develop, define, establish, 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 components or assembly parts they supply.
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 for quality engineering disciplines and statistics such as 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 Tandem’s incoming inspection, in-process inspection, final test, quality complaints, and as applicable product returns.