echojobs.io
Login

Hoya

Senior Quality Engineer

Ramsey, MN
ISO 13485 ISO 9001 FDA Six Sigma Minitab MS Outlook MS Word MS Excel ISO 14971
Search for More Jobs
Description

Senior Quality Engineer

Location: Ramsey, MN, United States

 

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 our Ramsey, MN location! 

Salary Range: $120K+ 

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:

 

  • Support the NA Quality Manager with QMS redevelopment and maintenance

  • Collaborate with cross functional teams and other departments to provide quality leadership, guidance, training, and support in QMS Implementation/execution. 

  • Support equipment qualification and development of plans and protocols (IQ/OQ/PQ)

  • Work closely with the project management team to ensure that our medical devices meet regulatory and quality requirements

  • Conduct risk assessments and participate in failure mode and effects analysis (FMEA) activities

  • Develop documentation (i.e. quality plans, procedures) to ensure compliance with applicable regulations

  • Participate in the development of product validation plans and support product validation testing

  • 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

 

 

 

 Qualifications:

 

  • 5+ years hands-on experience in medical device quality engineering

  • Experience with QMS development is a plus

  • Experience with FDA regulated products and ISO 13485 certified QMS

  • 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

  • Working knowledge of FDA regulations (21 CFR 820) and other relevant standards is strongly preferred

  • 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 preferred, with ASQ certification as a Quality Auditor being a plus

  • Experience in optics/opthalmics is a plus

  • Proficiency with Minitab, MS Outlook, MS Word, and MS Excel

  • Experience with ISO 14971 risk management is a plus

  • Bachelor’s degree (Engineering, Science, or related field preferred) or commensurate offsetting experience in Quality Engineering

 

 

 

 

 

 

 

About Us

HOYA Group: Founded in 1941 in Tokyo, Japan, HOYA Corporation is a global technology and med-tech company and a leading supplier of innovative high-tech and medical products. HOYA’s divisions and business units research and develop products utilized in the healthcare and information technology fields. In the healthcare field, we provide medical device products such as eyeglasses, medical endoscopes, contact and intraocular lenses, orthopedic implants, surgical/therapeutic devices and medical device reprocessing and disinfection solutions. In the information technology field, we provide products such as optical lenses, photomasks and blanks used in the manufacturing process for semiconductor and LCD/OLED devices, text-to-speech, human resources and other software solutions and critical components for the mass memory and cloud storage industries. With over 150 offices and subsidiaries worldwide, HOYA currently employs a multinational workforce of 37,000 people.

HOYA Vision Care: As a global leader in optical technology, HOYA Vision Care is dedicated to providing innovative vision care solutions for every stage of a patient’s life. A steadfast partner to Eye Care Professionals around the world, it stands at the forefront of optical excellence. With a global presence, consisting of 43 laboratories and a growing team of 20,000 employees, HOYA Vision Care delivers innovative lenses and other vision care solutions to millions of people in 110 countries.

We focus on a better tomorrow, today. You can become part of our story. HOYA Vision Care is the place where you can act according to your strengths and evolve according to your aspirations. It’s a place where you can shape the way you work, guided by our CLEAR Values, and empowered by generations of expertise. You can get involved in our sustainability initiatives and choose to become a One Vision ambassador. You can give back the gift of sight to people all over the world by deciding to work with us.

We welcome people who challenge us to become better, who share our sense of purpose and who embrace growth so that our vision and mission align. We invite you to find out more, and together we can continue to provide vision for a lifetime.

About the Organization

Driven by a passion for partnership as well as innovation, HOYA has been a partner to Eye Care Professionals for over 75 years, enabling them to give people the greatest gift, the gift of vision. We provide Eye Care Professionals with the lenses, consultation solutions and other services that help them to develop their practice while changing the way people see the world. We see them as visionaries, and everything we do is for them. Founded in Japan in 1941, today, HOYA has a presence in over 80 countries across the globe.SUMMARY The Senior Quality Engineer will support the Quality Manager in maintaining and upgrading the QMS in alignment with ISO 13485 / FDA compliance. This support will involve a leadership role within the department with specific focus on QMS development.
Hoya
Hoya

0 applies

0 views

There are more than 50,000 engineering jobs:

Subscribe to membership and unlock all jobs

Engineering Jobs

60,000+ jobs from 4,500+ well-funded companies

Updated Daily

New jobs are added every day as companies post them

Refined Search

Use filters like skill, location, etc to narrow results

Become a member

🥳🥳🥳 452 happy customers and counting...

Overall, over 80% of customers chose to renew their subscriptions after the initial sign-up.

To try it out

For active job seekers

For those who are passive looking

Cancel anytime

Frequently Asked Questions

  • We prioritize job seekers as our customers, unlike bigger job sites, by charging a small fee to provide them with curated access to the best companies and up-to-date jobs. This focus allows us to deliver a more personalized and effective job search experience.
  • We've got over 200,000 jobs from 15,000+ vetted companies. No fake or sleazy jobs here!
  • We aggregate jobs from 15,000+ companies' career pages, so you can be sure that you're getting the most up-to-date and relevant jobs.
  • We're the only job board *for* software engineers, *by* software engineers… in case you needed a reminder! We add thousands of new jobs daily and offer powerful search filters just for you. 🛠️
  • Every single hour! We add 2,000-3,000 new jobs daily, so you'll always have fresh opportunities. 🚀
  • Typically, job searches take 3-6 months. EchoJobs helps you spend more time applying and less time hunting. 🎯
  • Check daily! We're always updating with new jobs. Set up job alerts for even quicker access. 📅

What Fellow Engineers Say