Manager, Quality Assurance

Key Duties And Responsibilities

• Manages the implementation, and maintenance of the methods used to assure quality system compliance to applicable regulatory requirements.
• Consult to Manufacturing and Receiving/Inspection 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 Quality Assurance that all processes and product are in full compliance with all regulatory requirements.
• Adequately support is provided to Operations for the development, modification and qualification of manufactured components.
• Provides direction and support for the CAPA process to ensure effective root cause corrective action is implemented to address nonconformance.
• Directs the Quality Assurance departmental budget, ensuring a high level of fiscal responsibility within the organization.
• Ensures periodic analysis and reporting of key quality system performance metrics.
• Serves as Quality Management Representative for the specified manufacturing facility.
• Hosts and be responsible for all government inspections and QS Audits.

Minimum Requirements

• B.S. in Engineering or related discipline.
• Minimum 5 years’ experience in Manufacturing / Quality Assurance environments with at least 3-4 years in Medical Device manufacturing.

Preferred Requirements

• M.S. or MBA preferred.
• Quality Certifications (CQM, CQE, CQA, or Lead Assessor).
• Proficient in Microsoft Office Suite.
• Strong working knowledge of QMSR/ISO requirements.

Physical Requirements

• Ability to sit/stand for 8 hours.

ADA Disclosure

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Benefits

• Competitive compensation
• Excellent healthcare including medical, dental, vision and prescription coverage
• Short & long term disability plus life insurance -- cost paid fully by CONMED
• Retail 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

Contact Information

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 and does not discriminate on the basis of any legally protected status or characteristic.

Protected veterans and individuals with disabilities are encouraged to apply.

The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.

Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-929-7176 option #5.