Quality Engineer - Flanders, United States - Katalyst Healthcares and Life Sciences

Katalyst Healthcares and Life Sciences Flanders, United States

Found in: Lensa US 4 C2 - 4 days ago

Description

Responsibilities:
Support validation process through protocol drafting, approval and execution and providing validation training and guidance Chair Process Change Review Board and participate in Validation Review Board meetings Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead Lead improvement initiatives for Quality Assurance Independently perform full range of standard work Identify and resolve more complex problems and apply problems-solving skills to handle most situations Use statistical analysis and risk management techniques Provide guidance for process changes, including guidance on validation requirements Lead CAPA investigationsRequirements: In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports Proven ability to lead projects In-depth knowledge of requirements related to ISO 13485 and FDA QSR Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control Experience with product transfers and new product development projects Experience with problem solving techniques and CAPA investigations Strong organizational skills and ability to prioritize Experience working in medical device or regulated industry Proficient with Microsoft Excel, including use of pivot tables Perform statistical analysis using standard software such as Minitab Ability to make decisions and communicate effectively to multiple levels Bachelor's degree in science or engineering field of study Certified Quality Engineer (CQE) Six Sigma Certification experience preferred 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above

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Found in: Lensa US 4 C2 - 5 days ago

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