Quality Assurance Manager

The Quality Assurance Manager ensures compliance to FDA Quality System Regulations and ISO13485 standards for all quality system processes and procedures. They direct Quality Assurance and Quality Engineering activities to foster a culture of continuous improvement. They direct the Quality Assurance and Quality Engineering group in ensuring that all manufacturing processes conform to documented requirements.Key Duties and Responsibilities:Manage the implementation and maintenance of the methods used to assure quality system compliance to FDA QSR and ISO13485 requirements.Consult to Manufacturing and R&D through the Quality Engineering and Assurance groups to ensure proper use and understanding of quality tools.Ensure the type of inspections, tests, and measurement techniques used by Manufacturing and R&D that all processes and products are in full compliance with all regulatory requirements.Ensure adequate support is provided to Operations for the development, modification, and qualification of manufacturing.Manage the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance.Direct the Quality Assurance departmental budget, ensuring a high level of fiscal responsibility within the organization.Provide adequate budget to ensure Quality Engineering and Assurance groups are adequately trained and requirements are met to service the business.Ensure supervision of personnel in the Quality Assurance group (both direct and indirect reports) is conducted in a fair and consistent manner.Act as backup Quality Management Representative for the specified R&D facility.Host and be responsible for all government inspections and QS Audits.In addition to the main responsibilities listed above, the manager is allowed to use discretion to add further duties and tasks based on the business needs which are not explicitly listed here.Required Qualifications:B.S. in Engineering or related discipline.Minimum 8 years' experience in Manufacturing/Quality Assurance environments, with at least 3-4 years in Medical Device or other FDA regulated industries.Proficient in Microsoft Office Suite.Strong working knowledge of QSR/ISO requirements.Strong working knowledge of quality assurance and Manufacturing principles and practices.Ability to sit/stand for 8 hours.Preferred Qualifications:M.S. or MBA preferred.Quality Certifications (CQM, CQE, CQA, or Lead Assessor) desirable.This position is not eligible for employer-based sponsorship. Disclosure as required by applicable law, the annual salary range is 95,000-185,000. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED's good faith belief at the time of this posting.Benefits:CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.Competitive compensation.Excellent healthcare including medical, dental, vision, and prescription coverage.Short & long term disability plus life insurance -- cost paid fully by CONMED.Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period.Employee Stock Purchase Plan -- allows stock purchases at discounted price.Tuition assistance for undergraduate and graduate level courses.Know someone at CONMED?Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, citizenship status, or veteran status.If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.

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