Job Description
The Manager, Quality Assurance ensures compliance to applicable regulatory requirements for all quality system processes and procedures. Directs Quality Assurance and Quality Engineering activities to foster a culture of continuous improvement. The Manager, Quality Assurance will direct the Quality Assurance and Quality Engineering group to ensure all manufacturing processes conform to documented requirements.
***This is an on-site everyday role in Memphis, TN.***
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.
- Ensure adequate 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.
- Provides adequate budget to ensure Quality Engineering and Assurance groups are adequately trained and requirements are met to service the business.
- Ensures periodic analysis and reporting of key quality system performance metric
- Ensures supervision of personnel in the Quality Assurance group (both direct and indirect reports) is conducted in a fair and consistent manner.
- Act as Quality Management Representative for the specified manufacturing facility.
- Host and be responsible for all government inspections and QS Audits.
MINIMUM REQUIREMENTS
- 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 manufacturing.
- Minimum 2 years of leadership experience.
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.
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.
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 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.