Quality Engineer, Morristown, TN

(On-Site Position)

ONE TEAM. MANY TECHNOLOGIES.

One TEAM. Many Technologies. TEAM is a rapidly growing end-to-end manufacturing solutions provider for our customers. With over 30 years of experience and technology, TEAM provides seamless, turnkey processes proven to positively impact customer’s business.

Founded in 1988 by three entrepreneurs in Morristown, Tennessee, TEAM began with a single guiding principle: TEAM will grow by partnering with our customers to drive their growth. In the spirit of our founders’ guiding principles, we continue to grow by adding new technologies to broaden our capabilities and provide solutions for our customer partners. As ONE TEAM with MANY TECHNOLOGIES, we stand ready to be “YOUR PARTNER FOR WHAT’S NEXT”. You can find TEAM in fourteen locations across the United States and three international locations.

ONE TEAM. MANY OPPORTUNITIES

We are looking for our next TEAM member!

TEAM is seeking a Quality/Validation Engineer to work with our group in Morristown, TN. The ideal candidate will have experience working within FDA guidelines, specifically in a medical device manufacturing field. This is a new position created to support an exciting new opportunity at TEAM Technologies.

Position Summary

Your main objectives are to be involved with new product introductions (NPI) as well as support of existing products that have already been commercialized. This position requires a well-organized, detail-oriented, hands on engineer to support Quality, Manufacturing, and Engineering. The Quality Engineer must help maintain TEAM’s Quality Management System in accordance with FDA Regulations (21 CFR 820 and/or 21 CFR 210-211) and ISO standards (ISO 13485, ISO 9001).

Supervise, train, and assist personnel with TEAMs systems and procedures. Play a leading role in DOE and pre-validation activities, equipment qualifications (IQ/OQ/PQ), complaint resolutions, CAPA’s, and related monitoring systems.

How will you contribute to the team?

  • Assist in the development, implementation, and strict adherence to TEAM’s Quality Management System
  • Develop and execute DOE’s and pre-validation activities
  • Lead the maintenance and assist with the development of PFMEA’s
  • Lead the development and maintenance of Quality/Control Plans
  • Create or support the Validation team with writing qualification protocols and reports with input from Engineering, Operations, and relevant SME’s
  • Assist with internal non-conformities and complaint investigations
  • Lead Root Cause investigations and CAPA process using various quality tools (8D, why-why, fishbone, etc.)
  • Provide CAPA responses for customer issues and audit findings
  • Perform Gage R&R’s, MSA’s, and write test/inspection methods and procedures
  • Monitor and report KPI’s
  • Develops/reviews standards, policies, and procedures in support of DHF’s and DMR’s
  • Directs quality related activities in support of the Project Management Office (PMO), Manufacturing, Engineering, Purchasing, and
  • Commercialization
  • Supports Operations with Engineering changes
  • Supports Quality and Regulatory to meet quality objectives
  • Perform other duties as assigned.

What will you contribute?

  • Experience in quality management systems (i.e. ISO 13485, 9001)
  • Computer literate, including statistical processing software such as Minitab
  • Statistical Process Controls
  • Ability to work as a team member with multiple departments, and build relationships with internal and external suppliers and customers
  • Ability to work independently with little oversight
  • Bachelor’s in an Engineering discipline, preferred
  • CQE, highly preferred
  • Minimum 3 years’ experience in Quality or Engineering discipline
  • Prior experience working in an FDA regulated environment, medical device experience highly preferred

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The statements in this job description reflect general details as necessary to describe the principal functions of this job, the level of knowledge and skill typically required and the scope of responsibility. It should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences of relief, to equalize peak work periods or otherwise to balance workload. This classification specification does not constitute an employment agreement between Team Technologies, Inc. and employee. It is subject to change as the needs and requirements of the position change.

TEAM is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

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