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Principal Quality Engineer, BD (Becton, Dickinson and Company), Franklin Lakes, NJ
Title: Principal Quality Engineer, New Product Development, Medical Devices – QUA10061
Description
The Principal Quality Engineer will participate in
or lead medical device design and development planning, develop design
input, design output activities, Design History File management, design
transfer activities, change management and design reviews.
Prepare and review design verification and design validation
documentation. Prepare and review risk management
documentation. Review and approve product documentation and
drawings for medical devices. Support process development and
validation activities and assist with test method validations.
Support and coordinate Sterilization Studies, Shelf life studies and
Biocompatibility Studies. Use statistical tools including Minitab
software and analyzes data. Serve as a quality representative on
one or more project teams engaged in new product development for
medical devices. Responsible for assuring that each project is
developed and released meeting customer expectations, regulatory
requirements including 21CFR820, ISO 9001, ISO 13485, ISO 14971, MDD
93/42/EEC and ISO 10993.
Qualifications
Requires a Bachelor’s degree in Science or
Engineering + four (4) years experience in job offered or four (4)
years experience as a Quality Assurance Manager or any other job title
performing all listed job duties. Master’s degree can be
substituted for six (6) months experience. Must have legal proof
to work in the United States.
Profile
Job Category: Quality
Location: United States-New Jersey-Franklin Lakes
Shift: First Shift / Day Job
Relocation Available: Yes
To Apply:
http://www.bd.com/us/careers/
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