QMS Manager

Hoya
paid holidays, tuition reimbursement, 401(k)
United States, Minnesota, Ramsey
7000 Sunwood Drive NW (Show on map)
Dec 16, 2024
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 By applying to this job, you are agreeing to receive an initial text, which you will have the ability to opt out of upon receipt.