What are the responsibilities and job description for the QMS Manager position at Hoya?
We are currently hiring a Quality Management System (QMS) Manager
Location: Hoya Vision, 7000 Sunwood Dr NW, Ramsey, MN 55303
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:
- Implement, communicate, maintain and improve the Company's Quality Systems to establish compliance with ISO13485 and 14971 requirements.
- Work with Global Quality and Regulatory Groups to assure compliance to appropriate international and regulatory standards.
- Ensure compliance with relevant standards and legislation.
- Assemble and support team to maintain up-to-date quality system records
- Support all functional areas in their efforts to develop written procedures appropriate to their needs
- Work with Top Management for process control and improvements.
- Host audits by customers and ISO 13485 certifying body
- Host FDA inspections
- In conjunction with area management, establish training requirements for staff
- Issue periodic training to Quality staff
- Issue periodic training to Management Staff on key aspects of QMS
- Perform periodic audits of employee training records
- Assess staffing needs and direct training accordingly
- Hold weekly Quality Committee meetings with Top Management
- Provide reports for trending to management review
- Report on weekly activity to management team at staff meeting
- Prepare and deliver Management Review meeting
Qualifications:
- Bachelor's degree in science or engineering and 5-10 years' experience in Quality Assurance.
- Experience in 21 CFR820 and/or ISO13485 quality systems.
- Demonstrated experience working with contract manufacturers, suppliers, or distributors.
- Experience working with product development teams and processes.
- Demonstrated exceptional written and oral communication skills.
- Proficiency in Microsoft Office.
- Experience with QMS platforms, such as Agatha.
- Passion and alignment with our mission, vision, values & operating principles.
- Desire to own decisions and take responsibility for outcomes.
- Willingness to embrace personal and professional development
- Experience in transitioning of product from development into production and ongoing support.
- Ability to travel up to 20% (national and international). Trips to facilities in North America and potentially Thailand and/or Japan
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