Are you a quality expert with a passion for ensuring exceptional standards in the medical device industry? A leading Medical Firm, based in Washington, DC, is seeking a driven Medical Device Quality Planning Manager to lead quality initiatives and ensure regulatory compliance throughout the product lifecycle.
About the Firm:
Our client is an innovative leader in medical device technology, dedicated to improving patient outcomes through cutting-edge solutions. With a strong commitment to quality, safety, and regulatory compliance, they are at the forefront of healthcare advancement. As they continue to grow, they seek a strategic leader to join their quality team and drive excellence in product development and manufacturing.
Responsibilities of the Medical Device Quality Planning Manager:
- Quality Strategy Development: Crafting and executing quality plans that ensure compliance with industry standards and regulatory requirements.
- Regulatory Compliance: Overseeing quality processes to ensure all medical devices meet FDA, ISO, and other global regulatory standards.
- Cross-functional Collaboration: Working with R&D, manufacturing, and regulatory teams to integrate quality throughout the product lifecycle.
- Process Improvement: Implementing continuous improvements in quality systems, ensuring consistency and reliability in product design and manufacturing.
- Risk Management: Leading risk assessment and mitigation strategies to address potential quality issues.
- Audits & Training: Conducting internal audits and providing training to ensure company-wide adherence to quality processes.
Qualifications:
- Extensive Experience: Proven leadership in quality planning within the medical device or healthcare industry.
- Regulatory Knowledge: Deep understanding of FDA, ISO, and global medical device regulations and standards.
- Analytical Skills: Strong analytical and problem-solving skills to drive process improvements and resolve quality issues.
- Leadership Skills: Ability to lead, mentor, and inspire cross-functional teams to uphold the highest quality standards.
- Education: A bachelor’s degree in Engineering, Quality Management, or a related field; advanced certifications in quality management are a plus.
How to Apply:
If you’re an experienced quality planning professional ready to lead in the medical device industry, submit your resume and cover letter today, detailing your qualifications and vision for quality management. Be a part of a dynamic team that is committed to advancing healthcare through innovation and quality excellence!