Director - Medical Device QMS

SharkNinja • Needham, MA

42d

About The Position

The Director of Medical Device QMS for New Product Design will lead the quality management initiatives for the development of new medical devices and ensure compliance of product in market. This strategic role is crucial for ensuring that all new products are designed and developed in compliance with regulatory standards, promoting a culture of quality throughout the product lifecycle, and ensuring we are executing to our QMS policy and procedures.

Requirements

• Bachelor's degree in Engineering, Quality Assurance, Life Sciences, or a related field; advanced degree preferred.
• Minimum of 10 years of experience in quality management within the medical device or regulated consumer goods industries, with a focus on new product development.
• Deep understanding of regulatory requirements (FDA, ISO 13485) and quality management systems.
• Proven track record of successfully leading quality initiatives in a product development context.
• Strong leadership and interpersonal skills, with the ability to influence and engage cross-functional teams effectively.
• Excellent analytical and problem-solving skills, with a commitment to data-driven decision-making.
• Strong communication skills, capable of conveying complex information to diverse audiences.

Responsibilities

• QMS Strategy Development: Develop and implement the Quality Management System (QMS) for our medical device portfolio, ensuring alignment with regulatory requirements (e.g., FDA, ISO 13485).
• Cross-Functional Leadership: Collaborate with R&D, engineering, marketing, and production teams to integrate quality principles into the new product design process and legacy product maintenance to ensure quality is embedded from the outset.
• Regulatory Compliance Oversight: Ensure that all new medical devices meet applicable regulatory standards throughout the design and development phases, including managing submissions and audits.
• Risk Management: Lead risk management activities during the product design phase, conducting thorough assessments and ensuring appropriate mitigation strategies are in place.
• Training and Development: Establish training programs to promote quality awareness and best practices related to new product development among cross-functional teams.
• Quality Metrics and Reporting: Define and track quality metrics related to new product design, preparing regular reports for senior management that highlight compliance status, risks, and opportunities for improvement.
• Continuous Improvement: Drive initiatives to enhance the QMS processes related to new product design, leveraging feedback and data analysis to implement best practices.
• Stakeholder Communication: Act as the primary point of contact for quality-related inquiries concerning new product design, ensuring clear communication with internal and external stakeholders.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Industry: Electrical Equipment, Appliance, and Component Manufacturing
• Number of Employees: 1,001-5,000 employees