Sr. Supplier Quality Engineer

Trident Consulting Inc•Aliso Viejo, CA

2d•Onsite

About The Position

As a critical member of the Global Quality organization, the Sr. Supplier Quality Engineer II will support the oversight of suppliers/vendors utilized by in the development, manufacturing, and/or distribution of medical devices and pharmaceutical products. This person has primary responsibility for performing supplier/vendor assessments, on-site inspections, and monitoring performance of vendors/suppliers in accordance with the Supplier Quality Management program. This person will lead and drive assurance of Supplier Quality performance to ensure that suppliers meet all identified regulatory and specific requirements impacting component and/or product quality. Initiate, support, and lead, as applicable, the supplier quality related initiatives with suppliers to improve product quality and on-time delivery of contracted goods/services.

Requirements

8+ years of relevant working experience Required
Working understanding of 21CFR 210, 211, Annex 1, 21 CFR Part 820, ISO 13845 and ISO 14971 requirements Required
Strong knowledge of regulations applicable to pharmaceutical and medical device manufacturing. Experience in performing Quality System and supplier audits is highly desirable. Required
ASQ certifications preferred. CQA, CBA, CQE, CSSBB Required
Strong documentation skills, attention to detail and accuracy Required
Strong written/oral communication skills Required
Ability to work cooperatively and effectively in a team environment. Required
Experience in Suppler Management with manufactured products. Required
Experience with Quality Management Systems (QMS), Root Cause and Corrective Action. Required
Bachelor's Degree in Engineer Required

Nice To Haves

Experience in performing Quality System and supplier audits is highly desirable.

Responsibilities

Work with cross functional department to review and approve requests for new suppliers to determine the supplier risk level and supplier qualification requirements.
Determine classification risk level and qualification requirements for new suppliers.
Work with suppliers and legal department to create new or redline quality agreements and maintain quality agreements to support all the supplier’s quality requirement.
Maintain “Approved Suppliers List” (ASL) information in Oracle regarding the part numbers and service types for suppliers.
Submit and review changes to supplier classification, supplier risk level and supplier status.
Take necessary actions, including issuing Supplier Corrective Action Requests) to improve supplier performance.
Support maintenance of the Supplier Quality Records
Supplier Assessment schedule development and execution, including leading on-site and or on-site supplier audits.
Update supplier profiles or documentation as needed related to supplier changes.
Lead supplier performance management by analyzing performing data, identifying opportunities for improvement, and driving action on suppliers.
Drive resolution of Supplier Corrective Action Requests (SCARs).
Ensure continuous improvement and optimization of Supplier management procedures and processes.
Own the elimination of supplier product risk to improve reliability across the product lifecycle. Engage in Quality activities from concept through development and manufacturing to field use, with internal teams and suppliers.
Ensure the execution of product and process requirements with suppliers. Define and improve such requirements.
Work cross-functionally to ensure quality standards are being met. Facilitate smooth communication between the product team and suppliers.
Participate in the evaluation and improvement of suppliers. Frequent local car and occasional domestic air travel to visit suppliers (up to 50%)
Support the continuous improvement of the Quality Management System. Define and improve required documentation and activities.
Support investigations, initiatives, and projects as needed, at the team or organization level.