Quality Engineer Jobs

Quality Engineer

Hoya Optical

Ramsey, MN 55303

HOYA and Seiko Driven by passion for innovation and development, Hoya Vision is constantly moving boundaries. By use of extensive research and cutting- edge technology we provide tailored optimized experiences - both for the eye care professional and the spectacle wearer.

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 Quality Engineer

What’s in it for you?

• And more!
• Tuition Reimbursement
• PTO and Paid Holidays
• 401K plans
• Health/Dental/Vision/Disability Insurance

What you’ll do:

• Participate in the development of product validation plans and support product validation testing
• Support the Quality and Metrology Manager with QMS maintenance and development
• Develop documentation (i.e. quality plans, procedures) to ensure compliance with applicable regulations
• Work closely with the project management team to ensure that our medical devices meet regulatory and quality requirements
• 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
• Collaborate with cross functional teams and other departments to provide quality leadership, guidance and support in design control methodologies for medical device designs
• Support the Quality and Metrology Manager in maintaining the quality management system (QMS) and upgrading it to ISO 13485 certification / FDA compliance
• Conduct risk assessments and participate in design failure mode and effects analysis (DFMEA) activities
• This support will involve a leadership role with the enhancement of design control

Qualifications:

• Experience in a medical device start-up environment is a plus
• Experience with risk management tools, design controls, and process validation (IQ/OQ/PQ) is a plus
• Experience in product development including implementing appropriate controls
• Attention to detail and excellent problem-solving skills
• Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
• Experience in performing QMS audits is preferred, with ASQ certification as a Quality Auditor being a plus
• Ability to learn new software programs as required
• Find fulfillment in building and maintaining QMS’s
• 2+ years hands-on experience in medical device quality engineering
• Working knowledge of FDA regulations (21 CFR 820) and other relevant standards is strongly preferred
• Ability to work independently and in a collaborative team environment
• Excellent written and verbal communication skills
• Humble, hungry, and people smart with a willingness to learn and grow
• Ability to identify potential roadblocks and provide innovative solutions
• Operate with a high level of integrity and professionalism
• Ability to travel up to 5%
• Thrive in a dynamic environment with continually shifting priorities
• Experience with FDA regulated products and ISO 13485 certified QMS
• Working knowledge of statistics is required, with Six Sigma Green Belt (or higher) certification being a plus
• Bachelor’s degree in engineering, science, or related field
• Experience in optics/opthalmics is a plus

At HOYA, our foundation is built upon a diverse and inclusive work environment. Together, our differences are key to maintaining an inclusive culture that supports and inspires employee's uniqueness. Our differences ignite our innovation and connects us to our diverse customers and communities we serve.

We're passionate about maintaining an inclusive work environment, not only because it's the right thing to do, it promotes and celebrates differences. We are also committed to providing equal opportunity to people of all races, ethnicities, religions, genders, sexual orientations, gender identifications, disabilities, ages, philosophies, and veteran statuses at all levels of the organization.

Hoya and Seiko Optical is committed to providing equal opportunity in all employment practices, including but not limited to selection, hiring, promotion, transfer and compensation to all qualified applicants and employees without regard to age, race, color, national origin, religion, gender, handicap or disability, or any other category protected by federal state or local law.