Vice President, Quality Engineering – BSH Division

Hologic•Marlborough, MA

About The Position

The Vice President of Quality for the Breast and Skeletal Health Division is a pivotal executive leadership role responsible for developing and executing quality strategies across one of the largest divisions at Hologic Inc. This position ensures that all products meet the highest standards of safety, reliability, durability, and performance while maintaining compliance with regulatory requirements throughout the full product lifecycle—from new product development to post-market surveillance and product lifecycle management. As a member of both the Divisional Senior Leadership Team and the Global Quality Leadership Team, you will partner with divisional leadership to drive organizational goals, provide technical expertise, and influence cross-functional initiatives at the highest levels.

Requirements

In-depth understanding of FDA Quality System Regulations, ISO 13485, Medical Device Directive, Medical Device Regulation, risk management, and cybersecurity management.
Comprehensive knowledge of technical quality assurance and control systems, including standards, methods, and procedures for product inspection, testing, and evaluation.
Awareness of industry trends through review of technical publications and active engagement with regulatory authorities.
Demonstrated ability to lead and inspire senior leaders, including Directors, and manage large global teams.
Strong analytical and problem-solving skills at both managerial and technical levels.
Excellent written and oral communication skills, with the capacity to influence and present to regulatory bodies, technical functions, customers, field teams, and executive leadership up to the CEO.
Expertise in change management, independent decision-making, and conflict resolution.
Minimum of 14 years’ experience in technical roles within the medical device industry, with a focus on Quality and R&D.
At least 6 years in a personnel management role, including experience managing other people leaders.
Proven track record in product launch excellence, post-market quality management, and leading quality activities related to mergers and acquisitions.
Experience in developing, implementing, and maintaining Quality Management Systems to support regulatory and certification requirements.

Responsibilities

Developing and executing quality strategies across the Breast and Skeletal Health Division.
Ensuring products meet the highest standards of safety, reliability, durability, and performance.
Maintaining compliance with regulatory requirements throughout the full product lifecycle.
Partnering with divisional leadership to drive organizational goals.
Providing technical expertise and influencing cross-functional initiatives.
Championing innovation and continuous improvement by capturing and communicating lessons learned and driving the adoption of new tools, technologies, and methods.
Excelling in talent management, including attracting, hiring, developing, and retaining top talent, as well as managing succession planning and employee development.
Leading by example through objective setting, performance management, regular feedback, and recognition.
Promoting a culture of quality and compliance while fostering cross-functional collaboration and stakeholder engagement.
Hosting and managing third-party audits (e.g., FDA, notified bodies) and responding to regulatory findings.