Quality Engineering Manager
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Job Location:
North Charleston, SC - USA
Monthly Salary:
Not Disclosed
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB TITLE: Quality Engineering Manager
JOB DESCRIPTION: Use knowledge of and experience with: a regulated environment like medical device diagnostic instrumentation pharmaceutical or biotechnology; quality and lean Six Sigma methods such as DMAIC DoE FMEA MSA etc.; modular automation/fully automated assembly processes particularly those involving plastic injection molded parts and/or mechanical spring with integrated/non-integrated testing; entire Design life cycle and Phase-Gate development process; cGxP including ISO 13485 FDA 21 CFR 820 MDD 93/42/EEC; and statistical methods to support design transfer and product care activities with exposure to new process development through the application of Quality engineering skills for medical devices. Manage resources handle projects and tasks from process inception through process transfer scale-up and maintenance. Play active role in the processes to ensure products meet quality standards consistent with Customer Requirements while meeting regulatory requirements including but not limited to FDA Quality System Regulation 21 CFR Part 820 ISO 13485 and ISO 14971. Responsible for the implementation of SHL QMS processes that define development risk management process validation process transfer and supplier controls. Ensure that all related design control and production/process control projects meet applicable regulatory (local and international) Corporate Customer and Local QMS requirements. Develop quality plans and work with manufacturing on the transfer of manufacturing processes test methods and products. Support decisions on material disposition in case of process deviations. Promote the use of statistics in the verification and validation testing and control of quality. Promote Continuous Improvement and Lean Manufacturing processes. Manage a team of 7 Quality Engineers. Oversee quality engineering resources that support product development risk management process validation process transfer and supplier controls. Perform other related duties as assigned.
MINIMUM REQUIREMENTS: Requires a Bachelors degree in Mechanical Industrial Biomedical or Chemical Engineering or Material/Life Science (U.S. equivalent) plus five (5) years of experience evidencing demonstrable ability to perform the stated job duties. Requires working off-hours depending on project status and priorities (early morning late night or weekend depending on platform/product production status). New hires subject to drug test and background check.
JOB LOCATION: 3471 Trade Center Court North Charleston SC 29420
APPLICATION INSTRUCTIONS: Apply online search for Quality Engineering Manager vacancy at Experience:
Manager
Key Skills
About Company
SHL Medical is the world leader in designing, developing, and manufacturing advanced drug delivery devices like autoinjectors and pen injectors. Read on.
