The Quality Assurance Manager ensures compliance to CONMED QMS, FDA Quality System Regulations, ISO13485 standard and other regulations as required.. They direct Quality Assurance and Quality Engineering activities fostering a culture of compliance, customer service and continuous improvement. They direct the Quality Assurance and Quality Engineering group in ensuring that all manufacturing processes conform to requirements.
Key Duties and Responsibilities:
Manage the implementation, and maintenance of methods used to assure quality system compliance to FDA QSR and ISO13485 requirements.
Partner with Manufacturing, R&D, Engineering and other functions, through the Quality Engineering and Assurance groups, to ensure proper use and understanding of quality tools.
Ensure the type of product and process inspections, tests, validations/qualifications and measurement techniques used by Manufacturing, R&D, Engineering and other functions, are in full compliance with all regulatory requirements.
Ensure adequate support is provided to Operations for the development, modification, and qualification of manufacturing equipment, processes, procedures, etc.
Ensure processes are in place to address product handling and storage, reprocessing, rework, and product release consistently across manufacturing site.
Utilize the NC and CAPA process to ensure effective actions are implemented to address nonconformances.
Directly support and manage assigned area budget, ensuring a high level of fiscal responsibility within the organization.
Provide, Enable and Facilitate training and continued development to ensure Quality Engineering and Assurance groups are able 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.
Ensure a culture of safety is established and maintained.
Perform reviews of subordinates and oversee staffing of the Quality Engineering and Quality Assurance teams.
Evaluate/Propose resource needs to ensure appropriate organizational structure.
As needed, act as backup Quality Management Representative as appointed by the Site Quality Lead.
Directly support government and health authority 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.
Qualifications:
B.A. or B.S. in engineering, engineering management, or related technical or sciences discipline
Minimum 8 years' experience in Manufacturing/Quality Assurance environments; preferably with Medical Device or other FDA regulated industries.
Preferred Qualifications:
M.S. or MBA preferred
Quality Certifications (CQM, CQE, CQA, or Lead Assessor) desirable
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
This position is not eligible for employer-based visa sponsorship