US-MA-Charlton: Sr. Quality Assurance Engineer
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please visit http://sqa.fyicenter.com
Sr. Quality Assurance Engineer
# Write/execute design validation, design verification and/or process validation protocols.
# Participate in and/or lead efforts to implement new/revised regulatory standards.
# Support and/or lead Six Sigma initiatives.
# Support and/or lead continuous improvement efforts.
# Preparation and analysis of periodic Quality Reports.
# Performing internal and supporting external audits of products and processes.
# Selection, Qualification and monitoring of outside suppliers.
# Preparation of test and inspection procedures.
# Preparation and review/approval of Engineering Changes.
# Provide training and direction to manufacturing and QA personnel.
# Perform system and component defect analysis in conjunction with the continuous improvement program.
# Maintains overall responsibility for quality and work output of the department(s) supervised.
# Suvervise Technicians, which includes assigning work, scheduling, applicable decision making, overall knowledge of the department and its objectives and functions, floor support and necessary administrative functions as related to supervision responsibilities (e.g. salary administration, performance reviews, discipline, etc.).
# Meets and enforces all department and company regulations (e.g. quality, performance, attendance, teamwork, productivity, etc.)
# BS Degree in an Engineering discipline or equivalent experience.
# 5 years minimum experience in manufacturing and Quality Assurance of medical devices. Six Sigma experience and/or CQE/CRE/CQM preferred.
# Supervisory experience preferred.
# Strong basic statistics experience.
# Conversant with software applications for Microsoft Windows including Word, Excel, and Access.
# Ability to communicate effectively with personnel at all levels both verbally and in writing.
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Team SQAFYI - Software QA Resource FYI