Quality Engineer

3 weeks ago

Flanders, United States Katalyst Healthcares and Life Sciences Full time

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

  • Quality Engineer

    1 week ago

    Flanders, United States Ampcus Full time

    Position Overview This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional teams to determine validation activities required for projects as well as engineering and process changes. This person will support the...

  • Supplier Quality Engineer 3

    6 days ago

    Flanders, United States Katalyst Healthcares and Life Sciences Full time

    Responsibilities: Lead initiatives to improve quality received from assigned suppliers. Support the qualification of parts and/or introduction of new suppliers. Manage supplier's corrective action implementation through the Supplier Corrective Action process. Evaluate and disposition rejected material, as required. Use statistical analysis and risk...

  • Quality Control Inspector

    3 weeks ago

    Flanders, United States Birk Manufacturing Inc. Full time

    Job DescriptionJob DescriptionDescription:POSITION SUMMARY As a member of the Birk Manufacturing Quality Control team you will be responsible for inspecting, measuring and testing individual products to Birk Manufacturing and/ or customer specifications and requirements. This includes, but is not limited to, incoming inspection of raw material, in-process...

  • Design Engineer

    4 weeks ago

    Flanders, United States Birk Manufacturing Inc. Full time

    Job DescriptionJob DescriptionDescription:Summary/ObjectiveThe design Engineer is responsible for product design, creating production packages, and process development that help meet customer product requirements. The are responsible for designing circuitry and creating engineering drawings using AutoCAD. They are also responsible for managing projects and...

  • Maintenance Planner

    7 days ago

    Flanders, United States Akka Technologies Full time

    This position is part of the Engineering and Maintenance organization within the Technical Operations group and is responsible to ensure that all production process assets for the GMP Clinical and Commercial Cell Therapy Manufacturing facilities in Ghent (Belgium) are properly maintained, and all on-site reactive, preventive and predictive maintenance...

  • Maintenance Planner

    6 days ago

    Flanders, United States AKKA Technologies Full time

    This position is part of the Engineering and Maintenance organization within the Technical Operations group and is responsible to ensure that all production process assets for the GMP Clinical and Commercial Cell Therapy Manufacturing facilities in Ghent (Belgium) are properly maintained, and all on-site reactive, preventive and predictive maintenance...

  • Maintenance Manager

    7 days ago

    Flanders, United States Akka Technologies Full time

    For our client situated in region Ghent and active in biotechnology developing and manufacturing novel therapies, we are looking for a Maintenance Manager. Role Overview This position will be part of the Engineering and Maintenance organization within the Technical Operations group and will be responsible for managing the Maintenance team to ensure that...

  • Vehicle Crash/Automotive Expert

    3 weeks ago

    Flanders, United States Robson Forensic Full time

    Job DescriptionJob DescriptionVEHICLE CRASH EXPERT / AUTOMOTIVE EXPERT Do you want to use your training, education, and experience in a new and meaningful way?Our Automotive Crash Experts use their broad Engineering, design, and manufacturing experience to provide investigation, analysis, reports and testimony when technical and scientific answers are needed...