- 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
- Other duties as assigned
- 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
- Opportunity to work on various projects of various sizes
- Paid Time Off (PTO)
- Group Insurance; Medical, Dental, and Vision
- Company paid Basic Life Insurance
- Company paid Long-Term Disability Insurance
- Access to other voluntary benefits such as life Insurance for you and your family and short-term disability insurance
- 401(k) Savings Plan with employer match
- Employee Assistance Program (EAP)
- Company training programs
- Career opportunities across the United States
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Medical Device Quality/Validation Engineer - Morristown, United States - TEAM Technologies, Incorporated
1 week ago
Description
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.
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 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.
ONE TEAM. MANY OPPORTUNITIES.
About Us
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.
How will you contribute to the team?
What will you contribute?
What We Offer At TEAM
At TEAM, your benefits package includes:
To expand your career, apply today
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.
