Position Overview

The Senior Supplier Quality Engineer will be responsible for building strategic partnerships with suppliers and OEMs to ensure that supplier quality processes are meeting business goals and quality standards. The successful candidate will be a leader throughout the product lifecycle by participating in the development and estimation process, monitoring contracts, improving product quality, minimizing supplier costs, and driving selection towards the most efficient suppliers.

Responsibilities

• Lead supplier management process implementation to identify, select, qualify, onboard, and monitor suppliers
• Lead supplier quality management process implementation to assure product development, manufacturing, and sales and service functions have the resources necessary to achieve business objectives
• Provide input for supplier selection, provides key details and guidance to the SCM and project teams, to enable best choice of supplier.
• Develop relationships and interfaces with suppliers to maintain positive performance, and hold suppliers accountable when business or quality needs are not met.
• Be a leader in introducing and coordinating improvements through training, coaching, new quality tool implementation, authoring/editing standard operating procedures, and owning CAPAs, where appropriate
• Ensure supplier audit and Supplier Corrective Action Request (SCAR) processes are implemented effectively
• Apply quality system knowledge and exercise audit readiness skills and techniques within the organization and participate in external regulatory audits
• Facilitate implementation of quality strategies during make/buy process by aligning product development up front with procurement strategies
• Collaborate with Procurement, other Quality Engineer(s), and supporting staff to define, execute and improve on procurement and supplier processes.
• Interface with production and supply chain personnel on material delivery status, material discrepancy, damage, and shortage of material, related to any quality issues
• Review and approve documentation for compliance with US, EU, and other international regulations
• Identify and manage areas of potential noncompliance

Required Knowledge/Skills, Education, and Experience

* BA/BS in Engineering, or related scientific discipline

* 5-7 years' relevant experience in supplier quality assurance, procurement, and supply chain for IVD's

* Ability to apply advanced skills to resolve complex problems not covered by existing procedures or practices independently

* Strong networking and communication skills

* Excellent negotiation skills

* First-hand knowledge of applicable US (21 CFR 820) and EU (ISO 13485) quality system requirements, with a focus on: quality management, supplier controls, nonconformance, corrective and preventive action

* Highly developed writing and interpersonal skills with the ability to work on diverse teams located at different geographical locations
* 25% travel required (when travel restrictions are lifted)

Preferred Knowledge/Skills, Education, and Experience

* BS degree in Engineering, Molecular Biology or Biochemistry preferred

* 8+ years' relevant experience in supplier quality assurance, procurement, and supply chain for IVD's
* Lead auditor training (ISO 13485 or 9001) and 2+ years experience in conducting supplier audits

* Prior experience managing a supplier audit program (planning, scheduling, conducting, and reporting)

* Prior experience with managing a CAPA and/or SCAR program