Supplier Quality Engineer

• 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. 

Education Requirements

• 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