Quality Assurance Manager
4 days ago
The Quality Assurance Manager at CONMED Corporation 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 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 product 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.
Requirements:
- B.S. in Engineering or related discipline.
- Minimum 8 years' experience in Manufacturing/ Quality Assurance environments and 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.
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