QMS Manager

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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