Quality Engineer

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