Are you a driven quality assurance professional with a passion for ensuring the highest standards in medical device manufacturing? Join our top-tier healthcare client in New York, NY, as the Medical Device Quality Assurance Manager. We are seeking a dedicated leader to oversee quality assurance practices and help deliver innovative healthcare solutions to patients worldwide.
About Our Client:
Our client is a premier healthcare company, recognized for its excellence in developing cutting-edge medical devices that improve patient outcomes. With a relentless focus on safety, quality, and compliance, they are leading the future of healthcare technology. As they continue to expand, they are looking for an exceptional Quality Assurance Manager to ensure their products meet the highest regulatory and industry standards.
Responsibilities of Medical Device Quality Assurance Manager:
As the Medical Device Quality Assurance Manager, you will be responsible for:
- Quality Management: Overseeing the development and execution of quality assurance strategies for medical device products, ensuring adherence to both internal standards and external regulations.
- Compliance and Auditing: Managing compliance with FDA regulations, ISO standards, and other relevant regulatory requirements through regular audits and assessments.
- Process Improvement: Leading continuous improvement initiatives to enhance product quality, reduce defects, and ensure consistent performance across the production lifecycle.
- Risk Management: Conducting risk assessments and implementing preventive measures to minimize product quality issues and ensure patient safety.
- Cross-functional Collaboration: Working closely with R&D, manufacturing, and regulatory teams to maintain a cohesive approach to product quality and safety.
- Team Leadership: Leading and mentoring the quality assurance team to foster a culture of excellence and attention to detail.
Qualifications:
To excel in the role of Medical Device Quality Assurance Manager, you should possess:
- Industry Experience: Extensive experience in quality assurance within the medical device or healthcare industry.
- Regulatory Knowledge: In-depth understanding of FDA regulations, ISO 13485 standards, and other relevant quality management systems.
- Leadership Skills: Proven leadership and team management skills with the ability to inspire and guide quality assurance teams.
- Analytical Thinking: Strong analytical skills and the ability to identify and resolve quality issues through data-driven decision-making.
- Educational Background: A bachelor’s degree in Engineering, Quality Management, or a related field is required. Certifications like ASQ CQE or CQA are highly desirable.
How to Apply:
If you are a detail-oriented professional ready to lead and ensure the quality of life-changing medical devices, we invite you to submit your resume and a compelling cover letter highlighting your qualifications and vision for the role.
Ready to take the next step in your career in medical device quality assurance? Get in touch with us, the best Medical Device Recruiters, and explore more career opportunities. Apply today and be part of a team dedicated to advancing healthcare innovation!
