Quality Engineering Manager

SHL Medical•North Charleston, SC

1d•Onsite

About The Position

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.

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.

Responsibilities

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.