Senior Supplier Quality Engineer

This position will be responsible for the development and implementation of supplier-related quality system requirements including compliance with international and domestic regulations in support of new product development, manufacturing, and quality management system activities with a focus on continuous improvement.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Develop and maintain supplier-related procedures and requirements in compliance to FDA regulations, MDD, CMDR, and ISO requirements including evaluations, audits, and metrics
• Direct and support supplier-related activities, including:
  • QMS qualification and monitoring including supplier audits and assessments
  • Component (and sub-assembly) qualification elements such as defining requirements and assessing First Articles, Measurement Systems, equipment and process qualifications, Control Plans, etc.
  • Correction activities including managing NCRs and SCARs.
  • Supplier change requests and improvement
• Work closely with Quality Management, Product Development, and other departments in developing and executing company strategies
• Able to support both New Product Development activities at suppliers as well as sustaining activities for existing components and subassemblies.
• Able to work cross-functionally, overcome challenges, and facilitate cooperation with suppliers to meet regulatory requirements
• Assist with FDA and ISO audits. Perform internal and supplier audits as necessary
• Strong working knowledge of domestic and international standards and controls relevant to the duties and expectations of this position
• Operates with appreciable latitude for, and assumes ownership of, actions and/or decisions on day-to-day activities.
• Determines appropriate response to novel or controversial problems that may impact the business significantly
• Uses knowledge of best practices and technical proficiency in supplier quality engineering to mentor junior SQE’s. Other duties as necessary and assigned

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Regular and predictable work performance
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned