Supplier Quality Engineer

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.

• The individual must be capable of working independently and in a team, supporting the Quality, Production and Purchasing groups.
• 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.

• 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.

• Frequent performing repetitive work.
• Occasional lifting (max. 40 lbs.)
• Occasional carrying (max. 40 lbs.)
• Subject to physical hazards from moving equipment and machine parts.
• Constant safety glasses.
• Constant full PPE.
• Frequent standing.
• Occasional sitting, walking, pushing, pulling, reaching.
• Regular attendance in the office is required