Current jobs related to Quality Engineer - Flanders - Ampcus

  • Compliance Quality Inspector

    1 week ago

    Flanders, United States Birk Manufacturing Inc. Full time

    Job DescriptionWe are seeking a motivated and results-driven Compliance Quality Inspector to join our team at Birk Manufacturing Inc.The estimated salary for this position is around $58,000 per year, depending on qualifications and experience.This is an exciting opportunity to work in a fast-paced environment, contributing to the production of high-quality...

  • Senior Commercialization Engineer

    2 days ago

    Flanders, United States Insight Global Full time

    Job Summaryour client has an opening for a Senior Commercialization Engineer in the Corporate Supply Chain group, based out of the Flanders NJ location. The Senior Commercialization Engineer is responsible for supporting New Products Introductions & Formula Optimization by providing the link between product development R&D and manufacturing. This position...

  • Senior Commercialization Engineer

    6 days ago

    Flanders, United States Insight Global Full time

    Job Summaryour client has an opening for a Senior Commercialization Engineer in the Corporate Supply Chain group, based out of the Flanders NJ location. The Senior Commercialization Engineer is responsible for supporting New Products Introductions & Formula Optimization by providing the link between product development R&D and manufacturing. This position...

  • Chemical Commercialization engineer

    3 weeks ago

    Flanders, United States Insight Global Full time

    Job DescriptionJob DescriptionJob SummaryThe Senior Commercialization Engineer is responsible for supporting New Products Introductions & Formula Optimization by providing the link between product development R&D and manufacturing. This position supports new product and product improvement pipelines and will report directly to the Sr. Resin, PSM, &...

  • Senior Product Development Engineer

    1 week ago

    Flanders, United States Birk Manufacturing Inc. Full time

    Birk Manufacturing Inc.Product Development RoleThe Senior Product Development Engineer at Birk Manufacturing Inc. will be responsible for designing and developing innovative products, creating production packages, and process development to meet customer product requirements.Key Responsibilities:Create circuit designs and engineering drawings using AutoCAD...

  • Senior Commercialization Engineer

    1 month ago

    Flanders, United States Joulé Full time

    Title: Senior Commercialization Engineer (Corporate Supply Chain) Maximise your chances of a successful application to this job by ensuring your CV and skills are a good match. Location: Randolph, NJ Schedule: M-F Full Time Hours: M-F 8 am -4:30 pm, hybrid 2 days a week on site Type: Direct Hire Responsibilities: The Senior Commercialization Engineer is...

  • Sr Commercialization Engineer

    4 weeks ago

    Flanders, United States Benjamin Moore Full time

    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 unique...

  • Electrical Design Specialist

    1 week ago

    Flanders, United States Birk Manufacturing Inc. Full time

    About the RoleWe are seeking a skilled Electrical Design Specialist to join our team at Birk Manufacturing Inc. in [location]. This is a full-time position offering a competitive salary of $80,000 - $110,000 per year.Job ResponsibilitiesThe successful candidate will be responsible for designing and developing electrical systems and products, creating...

  • Industrialization Specialist

    4 weeks ago

    Flanders, New Jersey, United States Joulé Full time

    OverviewJoulé is seeking an experienced Industrialization Specialist to join our team. This role will be responsible for driving the commercialization of new products and processes, ensuring seamless transitions from research and development to large-scale manufacturing.Job DescriptionThe Senior Commercialization Engineer is a key position that supports New...

  • Product Scale-up Specialist

    1 week ago

    Flanders, New York, United States Insight Global Full time

    The estimated salary for this position is $120,000 - $180,000 per year.Job OverviewWe are seeking a highly skilled Product Scale-up Specialist to join our team at Insight Global. As a key member of our commercialization team, you will be responsible for supporting the successful launch of new products and process improvements.Key...

Quality Engineer

7 months 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