Staff Supplier Quality Engineer
About The Position
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 leading supplier audits/assessments while training other auditors. Composes and drives timely completion of 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, possibly including supplier education in these activities Manage and lead Supplier change requests and improvement Work closely with Quality Management and other departments in developing and executing company strategies – including possible leading of small group efforts. Work cross-functionally, overcome technical and logistical challenges, and facilitate cooperation with suppliers to meet regulatory requirements. Assist with FDA and ISO audits. As necessary, perform internal and supplier audits as Audit Lead.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, and driving completion of actions and/or decisions on day-to-day activities. Determines appropriate response to novel or controversial problems that may impact the business significantly and presents plans to resolve such problems. Uses knowledge of best practices, technical proficiency, and past experiences 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 performanceAbility 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
Requirements
- Bachelor’s degree with 6+ years of experience in Quality Engineering (at least 3 in Supplier Quality)
- FDA and ISO 13485 knowledge and multiple audit experiences
- Willingness to travel (~25%)f
- Demonstrated experience with inspection/testing and data analysis
- Strong computer/data entry, report writing, and communication skills.
- Greater use of tools above MS Office (ie. Visio, Power BI, etc) for communication and analysis.
- Statistical use experience – Assessing capability, running hypothesis tests
- Details-oriented with demonstrated problem solving/trouble shooting experience of larger magnitude.
- Must be able to read technical specifications, blueprints, and drawings.
- Working knowledge of GD&T
- Engineering/Manufacturing background – preferably machining, molding, and finishing processes
Nice To Haves
- Advanced degree
- MDD, CMDR and JPAL knowledge
- ASQ Certified Quality Engineer
- ASQ Certified Quality Auditor
Responsibilities
- 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 leading supplier audits/assessments while training other auditors.
- Composes and drives timely completion of 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, possibly including supplier education in these activities
- Manage and lead Supplier change requests and improvement
- Work closely with Quality Management and other departments in developing and executing company strategies – including possible leading of small group efforts.
- Work cross-functionally, overcome technical and logistical challenges, and facilitate cooperation with suppliers to meet regulatory requirements.
- Assist with FDA and ISO audits.
- As necessary, perform internal and supplier audits as Audit Lead.
- Operates with appreciable latitude for, and assumes ownership of, and driving completion of actions and/or decisions on day-to-day activities.
- Determines appropriate response to novel or controversial problems that may impact the business significantly and presents plans to resolve such problems.
- Uses knowledge of best practices, technical proficiency, and past experiences in supplier quality engineering to mentor junior SQE’s.
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
