Supplier Quality Engineer

Tegra Medical Holdings LLC•Franklin, MA

just now•Onsite

About The Position

The Supplier Quality Engineer is responsible for ensuring that the manufacturing facility's supplier's materials, processes, and final products are all high quality. The SQE role utilizes Quality & Process Engineering principles, tools, and practices to monitor, qualify and manage suppliers to support the overall business and quality vision of Tegra Medical.

Requirements

Strong engineering skills, problem analysis/solving.
Excellent written and oral communication skills.
Understanding of GMP, FDA and SOP standards, guidelines, and regulatory requirements.
Ability to work in a fast-paced manufacturing environment while managing multiple projects.
Strong engineering skills with working knowledge of the following: Process validation and verification activities. (IQ, OQ, PQ, PPQ). Risk analysis techniques, which include PFMEA (Process Failure Modes and Effects Analysis).
Manufacturing Control Plans and Flow Plans.
Blueprint & GD&T reading. Problem solving techniques, including root cause analysis, and cause and effect analysis.
Proficiency with Microsoft Office products (Word, Excel, Project, PowerPoint) and Minitab.
Experience in the Medical device is highly desired.
Hands-on experience in the manufacturing, quality & process disciplines.
A minimum B.S. in an engineering discipline preferably mechanical engineering or 5 + years' experience in a quality engineering equivalent role.

Responsibilities

Evaluating suppliers for compliance to minimum standards required to be added to Tegra's Approved Supplier List (ASL)
Monitor supplier performance and ensure timely responses to supplier nonconformances, SCARs or any other supplier quality issues.
Evaluate and provide guidance to suppliers for approval of process changes requested by supplier or on behalf of Tegra's request.
Complete supplier scorecards on regular intervals to provide feedback to the supplier as well as Tegra Purchasing and Production on supplier's performance.
Complete supplier audits on intervals defined based on risk to ensure supplier's conformance to Tegra's ASL requirements.
Work with Procurement to consolidate ASL between Tegra facilities to minimize the work required to maintain suppliers in multiple Tegra site locations.
Eliminate redundancy in the ASL where applicable to reduce the overall number of active suppliers.
Determine incoming inspection needs for purchased raw materials, component, etc. to meet Tegra's quality system or customer requirements.
Engage suppliers in Environmental, Health and Safety (EHS) initiatives to determine compliance to ESG standards (where applicable).
Determine potential cost savings with suppliers based on minimum order quantities, process capabilities and incoming inspection requirements.
Work with GTC, NPI and engineering to determine appropriate suppliers needed for product development.
Additional duties and responsibilities as required.