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Manager, Quality Engineering

Marlborough, MA, United States

We’re looking for a Manager, Quality Engineering for Quality Technical Investigations (QTI) to join our team at Hologic! In this critical leadership role, you’ll manage a multidisciplinary team responsible for technical complaint investigations, root cause analysis, and continuous improvement for our electromechanical in vitro diagnostics medical devices (IVDs). You’ll also play a pivotal role in ensuring the successful development and launch of safe, durable, and serviceable products.

If you’re a process-driven problem solver with a passion for cultivating high-performing teams and delivering exceptional results, we want to hear from you!

Knowledge

+ Deep understanding of Quality Management Systems (QMS), including ISO 13485 and FDA QMSR regulations.

+ Expertise in root cause analysis, CAPA, complaint investigations, and systemic issue resolution.

+ Knowledge of 5S principles for lab organization and safety.

+ Familiarity with new product development processes and lifecycle management for medical devices.

+ Advanced knowledge of electromechanical and IVD medical device standards and best practices.

Skills

+ Proven ability to lead, mentor, and develop multidisciplinary teams of engineers and technicians.

+ Systematic approach to identifying root causes, implementing corrective actions, and driving continuous improvement.

+ Strong ability to foster cross-functional partnerships with design, manufacturing, and service teams.

+ Expertise in developing and improving processes to maintain compliance, audit readiness, and efficiency.

+ Excellent written, verbal, and interpersonal communication skills to foster a solutions-oriented team culture.

+ Strong organizational and documentation skills with an emphasis on data-driven decision-making.

Behaviors

+ Takes responsibility for team outcomes and follows through on commitments.

+ Passion for delivering innovative, proactive solutions that exceed customer expectations.

+ Values discipline, consistency, and quality at the source in all processes.

+ Actively seeks opportunities to drive meaningful change and deliver measurable results.

+ Demonstrates respect, teamwork, and open communication across all levels of the organization.

+ Upholds high ethical standards and fosters a culture of trust and accountability.

Experience

+ 7+ years of quality engineering experience in the medical device industry, with a focus on electromechanical and IVD devices.

+ Proven track record in complaint investigations, CAPA processes, and regulatory compliance.

+ Experience in a leadership or management role, with direct responsibility for engineering or technical staff.

+ Hands-on experience supporting new product development and launches.

+ Familiarity with managing laboratory or technical workspaces, including implementing 5S principles.

+ Experience supporting regulatory audits and maintaining audit-ready processes.

+ Recognized certifications such as ASQ Certified Quality Engineer (CQE) are preferred but not required.

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 $119,700-$199,400 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 Department. In 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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