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.
Salary.com Estimation for QMS Manager in Ramsey, MN
$121,894 to $152,789
If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution.
Compensation Planning
Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right.
Surveys & Data Sets
What is the career path for a QMS Manager?
Sign up to receive alerts about other jobs on the QMS Manager career path by checking the boxes next to the positions that interest you.
Job Description We are currently hiring a Shipping Clerk Hours: Monday to Friday, 8:00am to 5:00pm Location: 289 Commerce Park Drive, Suite F, Ridgeland, M...more
Job Description We are seeking an experienced Director of Cost Accounting to join our dynamic manufacturing company. This role is pivotal as we transition ...more
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 hig...more
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 hig...more
