Overview:
We are seeking a highly skilled and experienced professional to join our team as the Director of Quality Affairs. Headquartered in Massachusetts, we are committed to developing innovative and life-changing medical devices that meet the highest standards of quality and compliance.
Responsibilities:
Provide strategic leadership in all aspects of quality management, ensuring compliance with relevant regulations and standards.
Develop and implement quality policies, procedures, and systems to support organizational objectives.
Demonstrate a deep understanding of EU MDR requirements and ensure the organization's adherence to these regulations.
Stay abreast of evolving regulatory landscape and provide guidance on compliance matters.
Lead, mentor, and manage a team of quality professionals, fostering a culture of excellence and continuous improvement.
Collaborate with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure a seamless integration of quality processes throughout the product lifecycle.
Develop and implement a comprehensive risk management program to identify, assess, and mitigate risks associated with product quality and regulatory compliance.
Qualifications:
Minimum of 8 years of experience in Quality Management within the medical device industry.
Proven experience managing at least 3 direct reports.
In-depth knowledge and practical experience with EU MDR regulations for medical devices.
Strong leadership and communication skills, with the ability to influence and engage stakeholders at all levels.
Demonstrated success in leading teams to achieve and maintain regulatory compliance.
Bachelor's degree in a relevant field; advanced degree preferred.
Relevant certifications (e.g., ASQ, RAPS) are a plus.