Vice President, Quality Engineering – BSH Division

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 lifecyclefrom 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.

Knowledge

• 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.

Skills

• 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.
• Proficiency in hosting and managing third-party audits (e.g. FDA notified bodies) and responding to regulatory findings.

Behaviors

• Champion innovation and continuous improvement by capturing and communicating lessons learned and driving the adoption of new tools technologies and methods.
• Excel in talent management including attracting hiring developing and retaining top talent as well as managing succession planning and employee development.
• Lead by example through objective setting performance management regular feedback and recognition.
• Promote a culture of quality and compliance while fostering cross-functional collaboration and stakeholder engagement.

Experience

• 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.

Why join Hologic

We are committed to making Hologic the destination for top talent. For you to succeed we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $237600 - $422400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience skillset knowledge education business needs and market demand.

Agency and Third-Party Recruiter Notice

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

Hologic Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

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