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 Quality Engineer in our Ramsey, MN location!The Quality Engineer is responsible for ensuring that products, processes, and quality systems comply with internal requirements, customer expectations, and regulatory standards. The Quality Engineer will support the Quality Department in establishment, maintenance, and continuous improvement of the QMS, risk management activities, validation and qualification programs, audits, CAPA investigations, and continuous improvement initiatives in alignment with ISO 13485/FDA compliance and other applicable regulatory requirements.

This position will work closely with Operations, Engineering, R&D, and Global/regional Quality functions to drive product quality, process effectiveness, compliance, and customer satisfaction supporting ATC (R&D), Mass Operations, and Rx functions.

What’s in it for you?

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

ESSENTIAL DUTIES AND RESPONSBILITIES

• Support the Quality Team with QMS establishment, maintenance, and continuous improvement
• Collaborate with cross functional teams to provide quality leadership, guidance, training, and support in QMS implementation/execution.
• Support validation activities including IQ/OQ/PQ and TMV for equipment and production line process validation
• Support software validation and computer systems validation activities as required
• Own and support CAPAs, deviation, and nonconformance investigations
• Conduct risk assessments and lead failure mode and effects analysis (FMEA) activities. Ensure risks are identified, evaluated, mitigated, and documented
• Develop documentation (i.e. quality plans, procedures) to ensure compliance with applicable regulations
• Serve as the quality representative on Design and Development projects supporting completion of DHF documentation
• Perform internal QMS/process audits and support external audits (i.e. ISO 9001, ISO 13485, FDA) to ensure compliance with quality and regulatory requirements
• Support supplier quality evaluations and monitoring (audits, SCAR and other)
• Participate in change management activities
• Perform data analysis, KPI monitoring, identify trends and opportunities for improvement
• Develop PCPs and support production lines as needed

EDUCATION AND QUALIFICATIONS

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

EXPERIENCE

• 5+ years hands-on experience in medical device quality
• 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 certification as a Quality Auditor being a plus
• Experience in optics/ophthalmics is a plus
• Proficiency with Minitab, MS Outlook, MS Word, and MS Excel
• Experience with ISO 14971 risk management is a plus

DEMONSTRATED ABILITIES

• Attention to detail and excellent problem-solving skills
• Excellent written and verbal communication skills
• Ability to identify potential roadblocks and provide innovative solutions
• Ability to work independently and in a collaborative team environment
• Operate with a high level of integrity and professionalism
• Ability to learn new software programs as required
• Ability to travel up to 10%
• Humble, hungry, and People-smart with a willingness to learn and grow
• Find fulfillment in building and maintaining QMS’s and supporting a quality culture
• Thrive in a dynamic environment with continually shifting priorities
• Ability to manage communication and training with knowledge of different training techniques

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.