Quality Engineer

4 weeks 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 validation roadmap for the site. This role will also support Design Transfer/Change Control projects as needed. This role requires excellent organizational skills, analytical problem-solving skills, the ability to effectively communicate at a technical level as well as with management, and in-depth understanding of quality system requirements.

Responsibilities
This position will be responsible for being the Quality Assurance lead for Validation as well as supporting Design Transfer and other change projects, including engineering and process change projects.

The person in this role will:
• 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 in order to handle most situations
• Use statistical analysis and risk management techniques
• Provide guidance for process changes, including guidance on validation requirements
• Lead CAPA investigations

Required Knowledge/Skills, Education, and Experience
• 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

Preferred Knowledge/Skills, Education, and Experience
• 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 month 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 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 Engineer

    3 days 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...


  • 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...


  • Flanders, United States AKKA Technologies Full time

    Role Overview The Quality person in plant is an exempt level position with responsibilities for providing quality oversight over the production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. Job duties are performed within a team according to an assigned, production shift schedule. This role...


  • 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...


  • Flanders, United States Nationwide Technical & Executive Search Full time

    Automation Controls EngineerFlanders, NJOnsite, Permanent, Full BenefitsRelecation Assistance availableAs an Automation & Controls Engineer, you will utilize your technical and communication skills to design, install and troubleshoot operations systems and equipment, develop and install new production processes, and participate in overall improvement...

  • Design Engineer

    2 months 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...

  • Design Engineer

    4 days 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...

  • Design Engineer

    3 days 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...


  • Flanders, United States Benjamin Moore Full time

    Automation Controls Engineer ID 2024-1414 Category Engineering Position Type Salaried Remote No Shift Time 8am-5pm Location Flanders, New Jersey Overview At Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a...


  • Flanders, United States Benjamin Moore Full time

    Automation Controls Engineer ID 2024-1414 Category Engineering Position Type Salaried Remote No Shift Time 8am-5pm Location Flanders, New Jersey Overview At Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a...


  • Flanders, United States Benjamin Moore Full time

    Overview: At Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a rewarding and inspiring work environment that fosters creativity, collaboration, and a strong sense of camaraderie. Our culture of excellence and transparency encourages our colleagues to bring their authentic selves and...


  • Flanders, United States Benjamin Moore Full time

    Overview: At Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a rewarding and inspiring work environment that fosters creativity, collaboration, and a strong sense of camaraderie. Our culture of excellence and transparency encourages our colleagues to bring their authentic selves and...

  • Maintenance Planner

    4 weeks 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

    4 weeks 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

    2 weeks 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

    4 weeks 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...

  • Maintenance Manager

    3 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...


  • 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...