Quality Engineer

4 weeks ago

Lowell, United States Lumicity Full time

Please apply or send your resume to klelix.hamlin@lumicity.io

The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.

**Essential Duties and Responsibilities:**

- **Quality System Management:**

- Maintain and improve the Quality Management System (QMS) in accordance with ISO 13485 and FDA regulations.

- Participate in internal and external audits, including preparing necessary documentation and follow-up on corrective actions.

- **Validation and Verification:**

- Design and execute validation protocols for new products and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

- Ensure all manufacturing processes, equipment, and materials meet pre-set quality standards.

- **Risk Management:**

- Conduct risk analysis and management throughout the product lifecycle in accordance with ISO 14971.

- Prepare and maintain Risk Management Files (RMF) for all products.

- **Product Quality Assurance:**

- Perform root cause analysis on product failures and implement corrective and preventive actions (CAPA).

- Review and approve product testing methods and final product releases.

- **Supplier Quality Management:**

- Work with suppliers to establish quality requirements for materials, components, and sub-assemblies.

- Conduct supplier audits and performance evaluations to ensure compliance with quality standards.

- **Documentation and Reporting:**

- Develop and maintain comprehensive documentation for quality assurance processes and procedures.

- Generate quality reports for management review, including trend analysis and quality performance metrics.

- **Training and Leadership:**

- Train and support production staff on quality assurance standards and practices.

- Lead cross-functional teams to address and resolve quality issues.

**Qualifications:**

- Bachelor's degree in Engineering, Quality, or a related field.

- 3+ years of experience in quality engineering within the medical device industry.

- Strong understanding of FDA, ISO 13485, and other regulatory standards.

- Proficiency in statistical analysis software and Microsoft Office Suite.

- Excellent communication and interpersonal skills.

- Strong analytical and problem-solving abilities.

  • Quality Engineer

    3 weeks ago

    Lowell, United States Lumicity Full time

    Please apply or send your resume to klelix.hamlin@lumicity.io The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards. **Essential...

  • Quality Engineer

    3 weeks ago

    Lowell, United States Lumicity Full time

    Please apply or send your resume to klelix.hamlin@lumicity.io The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards. **Essential...

  • Quality Engineer

    2 months ago

    Lowell, United States Lumicity Full time

    Please apply or send your resume to klelix.hamlin@lumicity.io The Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards. **Essential...

  • Quality Engineer

    2 months ago

    Lowell, United States Lumicity Full time

    Please apply or send your resume to klelix.hamlin@lumicity.ioThe Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.**Essential...

  • Quality Engineer

    2 months ago

    Lowell, United States Lumicity Full time

    Please apply or send your resume to klelix.hamlin@lumicity.ioThe Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.**Essential...

  • Quality Engineer

    4 weeks ago

    Lowell, United States Lumicity Full time

    Please apply or send your resume to klelix.hamlin@lumicity.ioThe Quality Engineer is responsible for overseeing the quality assurance of medical devices, from initial design through manufacturing and post-market surveillance. This role ensures that all products are manufactured in compliance with ISO 13485, FDA, and other regulatory standards.Essential...

  • Junior Quality Engineer

    1 week ago

    Lowell, Massachusetts, United States Michael Page Full time

    About Our Client My client specializes in delivering premier die-casting and engineered solutions to prominent manufacturers. With a focus on excellence, they offer comprehensive services from design and engineering to precision machining, assembly, and finishing, providing invaluable support at every stage of production.Job Description Focus on...

  • Quality Engineer II

    3 weeks ago

    Lowell, United States Cirtec Medical Full time

    CAREERS WITH AN IMPACT Cirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today's most advanced product technologies including, neuromodulation, implantable drug...

  • Quality Engineer II

    3 weeks ago

    Lowell, United States Cirtec Medical Full time

    CAREERS WITH AN IMPACTCirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today's most advanced product technologies including, neuromodulation, implantable drug...

  • Quality Engineer II

    3 weeks ago

    Lowell, United States Cirtec Medical Corporation Full time

    Job DescriptionJob DescriptionCAREERS WITH AN IMPACTCirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including,...

  • Quality Engineer II

    2 weeks ago

    Lowell, United States Cirtec Medical Corporation Full time

    Job DescriptionJob DescriptionCAREERS WITH AN IMPACTCirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including,...

  • Senior Quality Engineer

    13 hours ago

    Lowell, United States Actalent Full time

    A great opportunity to work with a well-known transportation company! Description: + Process documentation (Procedures, Process Maps, Job Aids, etc.) + Efforts in QA Reporting (Management Review, Quality Alerts, test records, 8D-Reports, etc.) + Supporting responsible departments in fulfilling QA requirements (by participating in supplier evaluation, audits,...

  • Junior Quality Engineer

    1 week ago

    Lowell, United States Michael Page Full time

    About Our Client My client specializes in delivering premier die-casting and engineered solutions to prominent manufacturers. With a focus on excellence, they offer comprehensive services from design and engineering to precision machining, assembly, and finishing, providing invaluable support at every stage of production. Job Description Focus on...

  • Quality Manager

    1 week ago

    Lowell, United States Actalent Full time

    Job Description: Process documentation QA Reporting (Management Review, Quality Alerts, test records, 8D-Reports, etc.) Manage audits, metrics (KPI), and approval processes Working on controlling continuous improvements (KVP, KVS, 5S, etc.) on production floor Supporting responsible departments in fulfilling QA requirements (by participating in supplier...

  • Quality Manager

    2 weeks ago

    Lowell, United States Actalent Full time

    Job Description: + Process documentation + QA Reporting (Management Review, Quality Alerts, test records, 8D-Reports, etc.) + Manage audits, metrics (KPI), and approval processes + Working on controlling continuous improvements (KVP, KVS, 5S, etc.) on production floor + Supporting responsible departments in fulfilling QA requirements (by participating in...

  • Quality Manager

    2 weeks ago

    Lowell, United States Actalent Full time

    Job Description: + Process documentation + QA Reporting (Management Review, Quality Alerts, test records, 8D-Reports, etc.) + Manage audits, metrics (KPI), and approval processes + Working on controlling continuous improvements (KVP, KVS, 5S, etc.) on production floor + Supporting responsible departments in fulfilling QA requirements (by participating in...

  • Quality Control Technician I

    2 weeks ago

    Lowell, United States Cirtec Medical Corporation Full time

    **CAREERS WITH AN IMPACT** **Cirtec Medical** - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including, neuromodulation,...

  • Quality Control Technician I

    3 weeks ago

    Lowell, United States Cirtec Medical Corporation Full time

    Job DescriptionJob DescriptionCAREERS WITH AN IMPACTCirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including,...

  • Quality Control Technician I

    2 weeks ago

    Lowell, United States Cirtec Medical Corporation Full time

    Job DescriptionJob DescriptionCAREERS WITH AN IMPACTCirtec Medical - is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities. Cirtec Medical specializes in complex, difficult to produce components and devices in today’s most advanced product technologies including,...

  • Manufacturing engineer

    3 weeks ago

    Lowell, United States Randstad Full time

    job summary: A Manufacturing Engineer is needed for an industry leader in recreational boats, marine engines, marine parts and accessories in the Lowell, MI area. The role of a manufacturing engineer involves applying engineering principles to improve industrial layout and production efficiency, interpreting engineering drawings and blueprints, and ensuring...