Quality Assurance Manager for Medical Device Development
1 week ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Integra LifeSciences. This role will be responsible for ensuring the efficacy of critical control programs, including calibration and preventive maintenance, environmental monitoring, change management, etc.
About the RoleThe successful candidate will have a minimum of 5+ years of experience in quality assurance and will possess excellent organizational, communication, and project management skills. They will also have a strong understanding of statistically based sampling plans, application of analytical tools, and data driven decision-making.
The estimated salary for this position is $120,000 - $150,000 per year, depending on qualifications and experience.
Key Responsibilities- Maintain a thorough understanding of international standards and regional regulations, including FDA QMSR (21 CFR Part 820), ISO 13485, and Regulation 2017/745 (EUMDR).
- Support the launching of new or improved products/processes and facilitate the transfer of technology from development to commercialization.
- Facilitate management of changes in device design and manufacturing procedures for commercialized devices.
- Authoring, editing, and providing guidance on the development and implementation of new and updated documents, including validation protocols and reports, product & material specifications, design & development documentation, SOPs, quality investigations, plans, and QMS support documents.
- Minimum of 5+ years of experience in quality assurance.
- Bachelor of Science or higher; Master's degree is preferred.
- American Society for Quality (ASQ) or Regulatory Affairs Professionals (RAPS) certificates or similar are preferred.
This is an exciting opportunity for a motivated and experienced professional to join our team and contribute to the development of innovative medical devices.
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