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Manager, Quality Engineering

Marlborough, MA, United States

Why Hologic?

Hologic empowers people to live healthier lives everywhere, every day. We are the leading Innovator in women's health, helping healthcare professionals around the world diagnose and treat their patients with precision, certainty and confidence.

The Manager of Quality Engineering will lead quality strategies to ensure compliance with regulatory requirements and the delivery of safe, high-quality medical devices. This role focuses on developing and implementing advanced quality engineering practices, including process validation, test method validation, and production process controls to ensure manufacturing performance and reduce risks.

What to Expect:

Team Development and Quality Culture Leadership

+ Set and Oversee SMART Goals: Establish and manage SMART (Specific, Measurable, Achievable, Relevant, Time-bound) goals for the Quality team to drive continuous improvement and align with organizational objectives.

+ Training and Development: Identify skill gaps and provide targeted training to enhance team capabilities, supporting both business priorities and individual growth.

+ Coaching and Mentorship: Provide personalized guidance and support through one-on-one or group interactions, fostering professional development, enhancing problem-solving skills, and empowering individuals to achieve their full potential.

+ Quality Culture Leadership: Promote quality initiatives site-wide, integrating quality standards, standard work, and continuous improvement principles into all areas of the business while cultivating an engaged workforce.Manager, Quality EngineeringManager, Quality Engineering, Rev. 004 HOLOGIC INC. - COMPANY CONFIDENTIAL Page 2 of 3Release Date: 03JUN2025 Before using this document, please consult Agile for the latest revision.QUA-1700-T02 Rev. 002

Leadership and Compliance:

+ Team Oversight: Manage and provide technical leadership to the Quality Engineering team, ensuring alignment with organizational goals and compliance expectations.

+ Audits: Act as a subject matter expert (SME) for internal and third-party inspections, including those conducted by the FDA, notified bodies, and other regulatory agencies.

+ Quality System Compliance: Ensure adherence to applicable regulatory standards, including ISO 13485, FDA QMSR and other applicable requirements.

+ Review and approve document changes for Quality Engineering functions as required.

+ Prepare and present reports on quality metrics, initiatives, and quality performance to senior leadership.

What we Expect:

+ Production Process Controls: Develop and implement robust controls to ensure product conformity, reduce variability, and align manufacturing practices with regulatory and quality standards.

+ Process Standardization: Drive process standardization, risk mitigation, and preventive measures to achieve production quality targets.

+ Customer Experience: Collaborate cross-functionally to ensure products meet customer expectations, addressing concerns proactively and driving continuous improvement.

+ Process Validation (IQ/OQ/PQ): Oversee and execute process validation activities to ensure compliance with internal and regulatory requirements.

+ Test Method Validation (TMV): Lead test method validation to ensure testing methods are accurate, repeatable, and reproducible.

+ Statistical Analysis: Leverage statistical tools (e.g., SPC, DOE, Minitab) for data-driven decision-making, process optimization, and variability reduction.

+ Risk Management: Apply tools such as Failure Mode and Effects Analysis (FMEA) to ensure product and process reliability.Continuous Improvement

Education & Experience:

+ Preferred Minimum Non-Technical Degree: College Degree

+ Preferred Minimum Technical/Advanced Degree: Master’s Degree

+ Preferred Minimum Non-Technical Degree: 8+ Years

+ Preferred Minimum Technical/Advanced Degree: 6+ Years with Master’s Degree, 3+ Years with PhD

+ Experience working in regulated medical device industry

+ Experience with 483, warning letter or consent decree remediation efforts preferred

_Must follow all applicable FDA regulations and ISO requirements._

The annualized base salary range for this role is $120,000 to $199,000 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, 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._

_\#LI-PR1_