HOYA Vision Care
QMS Manager
HOYA Vision Care, Saint Paul, Minnesota, United States,
Job Description
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 InsuranceTuition Reimbursement401K plansPTO and Paid HolidaysAnd 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 recordsSupport all functional areas in their efforts to develop written procedures appropriate to their needsWork with Top Management for process control and improvements.Host audits by customers and ISO 13485 certifying bodyHost FDA inspectionsIn conjunction with area management, establish training requirements for staffIssue periodic training to Quality staffIssue periodic training to Management Staff on key aspects of QMSPerform periodic audits of employee training recordsAssess staffing needs and direct training accordinglyHold weekly Quality Committee meetings with Top ManagementProvide reports for trending to management reviewReport on weekly activity to management team at staff meetingPrepare and deliver Management Review meetingQualifications:
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 developmentExperience 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.
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 InsuranceTuition Reimbursement401K plansPTO and Paid HolidaysAnd 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 recordsSupport all functional areas in their efforts to develop written procedures appropriate to their needsWork with Top Management for process control and improvements.Host audits by customers and ISO 13485 certifying bodyHost FDA inspectionsIn conjunction with area management, establish training requirements for staffIssue periodic training to Quality staffIssue periodic training to Management Staff on key aspects of QMSPerform periodic audits of employee training recordsAssess staffing needs and direct training accordinglyHold weekly Quality Committee meetings with Top ManagementProvide reports for trending to management reviewReport on weekly activity to management team at staff meetingPrepare and deliver Management Review meetingQualifications:
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 developmentExperience 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.