Description: The selected Supplier Quality Engineer will be responsible for the following;

Supply Chain Management - Overall support supplier quality management programs, including more substantive hands-on problem solving and continuous improvement initiatives to raise performance/productivity with suppliers and supply chain.

- Own, maintain and report on corporate Supplier Ratings process for strategic suppliers. Refine and maintain company Supplier Survey documentation.

- Work with internal customers (i.e., Engineering, Sales, Regulatory, and Fulfillment) to ensure effective problem resolution relating to supplier product/services. Define and establish company Supplier Change Request (SCR) process. Evaluate and determine internal requirements for approval of all specific SCRs and facilitate the flow of required activities.

- Lead and maintain Supplier Audit Process, working with the Regulatory Department. Manage all audit and non-conforming product corrective actions (i.e. SCAR).

- Coordinate and own the Approved Supplier List/process, including audit for non-compliance/renewals and revisions as required.

- Coordinate Supplier Quality Agreement Process in conjunction with Legal and Regulatory as required. Work with critical suppliers to develop relevant Control Plans, PFMEAs, Work Instructions and Acceptance Standards.

Supply Chain Development - Support vendor selection/advanced surveillance/ risk assessment. Ensure that suppliers` manufacturing and quality systems, special processes and products meet purchase contract requirements and applicable regulatory and government regulations.

- Work with Engineering to develop proper key characteristics on drawings.

- Coordinate First Article inspection and qualification activities, including more on-site assessment of supplier production process and controls if necessary. -

Requirements:

Minimum 5-7 years industry experience

- College level or equivalent is preferred or at management discretion

- Experience with manufacturing ERP systems

- Ability to manage multiple tasks, effectively utilize PC applications and have a sense of urgency in a fast paced environment

- Strong initiative and leadership skills needed

- Professionalism and articulation skills a must. In addition, strong communication skills and the ability to handle difficult issues

- Strong written and verbal communication skills and demonstrated supplier interaction skills

- Attention to detail and quality control

- Basic knowledge of ISO 13485 Medical Devices

- Quality Management System and FDA 21 CFR Part 820 Quality System Regulation

Pay Rate:

Based on Experience

NOTE: Applicant must be presently authorized to work in the United States. This company does not sponsor individuals for the purpose of obtaining H-1 Visas.

Unless the body of this posting specifically states otherwise, NO relocation allowance or per diem is available. CANDIDATES WITHIN A REASONABLY COMMUTABLE DISTANCE OF THE ABOVE WORK SITE ARE PREFERRED.

HOW TO APPLY:

PDSI Technical Services, Inc.