Senior Supplier Quality Engineer

POSITION SUMMARY:

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

BASIC QUALIFICATIONS:

Bachelor’s degree required or demonstrated equivalent combination of education, training and experience.

4+ years of experience

FDA and ISO 13485 knowledge and audit experience

Willingness to travel

Experience with inspection/testing and data analysis

Strong computer/data entry, report writing, and communication skills

Details-oriented with strong problem solving/trouble shooting experience

Must be able to read technical specifications, blueprints, and drawings

Engineering/design background

Ability to travel 25%

PREFERRED QUALIFICATIONS:

MDD, CMDR and JPAL knowledge

ASQ Certified Quality Engineer

ASQ Certified Quality Auditor or ISO13485 Lead Auditor certification

Statistical use experience

Experience with Metal Injection Molding (MIM) suppliers

OTHER REQUIREMENTS:

Ability to regularly walk, sit, or stand as needed

Ability to occasionally bend and push/pull as needed

Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds

Ability to pass pre-employment drug screen and background check

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