Sr Quality Engineer

1 month ago


Ramsey, United States HOYA Vision Care Full time
Job Description

Join The Hoya Vision Care Team

For over 60 years, HOYA Vision Care has been a passionate leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, we continuously aim to bring the best possible vision care solutions to eye care professionals.

We are currently hiring a Senior Quality Engineer in Ramsey, MN

What's in it for you?
  • Health/Dental/Vision/Disability Insurance
  • Tuition Reimbursement
  • 401K plans
  • PTO and Paid Holidays
  • And more
What you'll do:
  • Work in an environment using a risk-based approach (ISO 14971).
  • Lead equipment Verification & Validations (V&V) and development of plans and protocols (IQ/OQ/PQ).
  • Work closely with the project management team and Regulatory Affairs to ensure that our medical devices meet regulatory and quality requirements.
  • Collaborate with cross functional teams and other departments to provide quality leadership, guidance and support in design control methodologies for medical device designs.
  • Develop product validation plans and support product validation testing.
  • Support the Quality Manager with QMS maintenance and development.
  • Perform internal QMS audits to ensure compliance with quality requirements.
  • Support the Quality Manager with external audits (i.e. ISO 9001, ISO 13485, FDA).
  • Investigate and document non-compliances, identify root causes, and develop corrective and preventive actions.
  • Conduct risk assessments and participate in design failure mode and effects analysis (DFMEA) activities.
  • Develop documentation (i.e. quality plans, procedures) to ensure compliance with applicable regulations.
Qualifications:
  • Bachelor's degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering.
  • 5+ years hands-on experience in medical device quality engineering.
  • Experience with FDA regulated products and ISO 13485 certified QMS.
  • Experience with ISO 14971 risk management tools, design controls, and equipment/process validation (IQ/OQ/PQ).
  • Experience in product development including implementing appropriate controls.
  • Working knowledge of statistics is required, with Six Sigma Green Belt (or higher) certification being a plus.
  • Experience in a medical device start-up environment is strongly preferred.
  • ASQ certification as a Quality Engineer is a plus.
  • Experience in performing QMS audits is a plus.
  • Experience in a medical device start-up environment is a plus.
  • Experience in optics/opthalmics is a plus.
  • Proficiency with Minitab, MS Outlook, MS Word, and MS Excel.

  • Quality Engineer

    5 months ago


    Ramsey, United States Life Fitness Full time

    *Join us as we empower the world to work out, creating healthier lives together. * *About the Opportunity: * JOB PURPOSE: Develops, implements, and coordinates product and process quality assurance programs to prevent or eliminate defects in new or existing products. ESSENTIAL JOB FUNCTIONS: Perform root cause analysis and implementation of corrective...

  • Sr. Program Manager

    2 days ago


    Ramsey, United States Hoya Full time

    Join The Hoya Vision Care Team! For over 60 years, HOYA Vision Care has been a passionate leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, we continuously aim to bring the best possible vision care solutions to eye care professionals. We are currently hiring a Sr. Program Manager to work in Ramsey,...

  • Sr. Program Manager

    3 months ago


    Ramsey, United States Hoya Full time

    Join The Hoya Vision Care Team! For over 60 years, HOYA Vision Care has been a passionate leader in optical technology innovation. As a manufacturer of high quality, high performing eyeglass lenses, we continuously aim to bring the best possible vision care solutions to eye care professionals. We are currently hiring a Sr. Program Manager to work in Ramsey,...


  • Ramsey, United States HOYA Vision Care Full time

    **HOYA Vision Care: A Leader in Optical Technology Innovation**We are a passionate leader in optical technology innovation, committed to bringing the best possible vision care solutions to eye care professionals.Join Our Team as a Senior Quality EngineerSalary: $120,000 - $150,000 per year, based on experience and qualifications.About the RoleWe are...


  • Ramsey, United States Disability Solutions Full time

    Key ResponsibilitiesThe Quality Systems Specialist will play a crucial role in ensuring that Anderson Dahlen's quality management systems meet the highest standards of excellence. Key responsibilities will include developing, implementing, and maintaining a system of quality and reliability testing for production and development processes, ensuring...


  • Ramsey, United States Disability Solutions Full time

    Anderson DahlenDescription:WHY ADI?For 75 years, Anderson Dahlen has provided world-class metal fabrication and equipment integration services to leading companies in a wide variety of industries:Food ProcessingIndustrialPharmaceuticalVacuum (Applied Vacuum Division)Contract manufacturing for OEMs, engineering support and design-build capability for custom...


  • Ramsey, United States MMT Full time

    About Us:At MMT, we are dedicated to setting the standard in automation, machine design, material handling, and custom tooling. Our team members drive our success by upholding values of accountability, responsiveness, and a solutions-oriented approach. We’re searching for an experienced and motivated Manufacturing Engineer to serve as a vital link between...


  • Ramsey, New Jersey, United States Port View Resources Full time

    **Job Title:** Manufacturing Quality Control Manager**Job Description:** We are looking for a detail-oriented and organized individual to fill the role of Manufacturing Quality Control Manager at Port View Resources.This position involves overseeing the quality control process, ensuring that all products meet customer specifications and company standards....


  • Ramsey, United States MMT Full time

    Production Engineering Lead:Join MMT as a Production Engineering Lead and contribute to the development of innovative production processes that drive business growth and excellence. As a key member of our engineering team, you will collaborate with cross-functional teams to design, develop, and implement efficient production processes, ensuring high-quality...


  • Ramsey, New Jersey, United States MMT Full time

    **Job Overview**We are seeking an experienced Quality Assurance Manager to oversee our manufacturing processes and products. The successful candidate will be responsible for ensuring the quality of our operations through rigorous inspections, testing, and audits.**Responsibilities:**Program and operate CMMs for precision inspections and ensure adherence to...


  • Ramsey, New Jersey, United States MMT Full time

    Job OverviewThe Senior Quality Assurance Specialist will play a critical role in ensuring the quality of our manufacturing processes and products. This position requires expertise in quality systems, including CMM programming, QMS software management, and ERP quality module oversight.Key ResponsibilitiesCMM Programming & Inspection: Develop and execute...


  • Ramsey, MN, United States Anderson Dahlen Full time

    About the RoleWe are looking for a talented Quality Assurance Manager to lead our quality assurance team at Anderson Dahlen.The ideal candidate will have a strong background in quality engineering, manufacturing engineering, or a related field, with at least 5 years of combined experience in manufacturing/quality engineering and supervisory roles.Key...

  • Project Lead

    4 weeks ago


    Ramsey, United States Hoya Full time

    The Sr. Program Manager role at Hoyavisioncare is ideal for a motivated and results-driven individual who thrives in a fast-paced environment. As a leader, you will be responsible for setting priorities, developing project plans, and managing budgets.Key qualifications for this position include a bachelor's degree in business or engineering, PMP...


  • Ramsey, United States Bolton & Menk, Inc. Full time

    Bolton & Menk, Inc. is a leading provider of community infrastructure solutions with over 75 years of experience.">We are seeking a highly skilled Civil Engineer to join our Municipal team in Ramsey, Minnesota.Job DescriptionThis is an entry-level civil engineering role that offers the opportunity to work on a wide range of municipal projects.Assist project...

  • Validation Engineer

    2 weeks ago


    Ramsey, United States Delta Industrial Services, Inc. Full time

    Position Profile: This position is responsible for providing quality technical support, documentation and validation testing of production for custom automated converting, packaging, and coating equipment. Essential Functions: Write validation test protocols and technical reports. Perform monitoring, sampling, and testing to validate equipment, systems,...


  • Ramsey, United States The Okonite Company Full time

    Job OverviewThe Okonite Company is seeking an experienced Electrical Systems Engineer Lead to join our team in Ramsey, NJ.Estimated Salary Range$120,000 - $180,000 per year, depending on experience.ResponsibilitiesWe are looking for a highly skilled and motivated individual to lead our electrical systems engineering team. Key responsibilities...


  • Ramsey, United States The Okonite Company Full time

    Job OverviewThe Okonite Company is seeking a skilled Mechanical Engineer to join our Facilities Engineering Department. This exciting opportunity will allow you to take part in capital improvement projects, as well as continuous improvement efforts.As a Facilities Mechanical Engineer, you will be responsible for project management functions, including scope...


  • Ramsey, United States Anderson Dahlen Full time

    Company Overview">Anderson Dahlen is a world-class metal fabrication and equipment integration services provider to leading companies in various industries. With 75 years of experience, we offer contract manufacturing for OEMs, engineering support, and design-build capabilities for custom projects.About the RoleWe are seeking an experienced Product...


  • Ramsey, United States Bolton & Menk, Inc. Full time

    Company OverviewBolton & Menk, Inc. specializes in providing community infrastructure solutions, dedicated to improving quality of life through engineering excellence and client satisfaction since 1949. With over 1,000 employees across more than 35 locations, we offer services to over 400 communities and agencies.


  • Ramsey, United States The Okonite Company Full time

    Job DescriptionJob DescriptionJOB SUMMARY:The Applications Engineer is responsible for providing technical data as needed for inquiries, from Sales or customer requests. The Applications Engineer is also responsible for taking assignments from superiors, implementing plans and conducting the necessary work, and reporting results.ESSENTIAL DUTIES AND...