Full-Time

Service Quality Engineer Lead

Hologic

Hologic

5,001-10,000 employees

Develops medical devices for early detection

Compensation Overview

$120.1k - $188k/yr

+ Bonus

United States

In Person

Category
QA & Testing (1)
Requirements
  • Bachelor’s degree (B.S.) in engineering (electrical, mechanical, software, or computer) required.
  • M.S. preferred, with 8-12 years related industry experience.
  • Quality Engineer certification preferred.
  • Commitment to excellence and high standards, with strong organizational and analytical skills.
  • Possesses strong understanding of core process methodologies and problem-solving techniques related to primary role.
  • Possesses ability to generate and explain detailed proposals, guidelines, and procedures for the Quality Engineering functions to departmental and/or non-departmental personnel.
  • Ability to manage priorities and workflow.
  • Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
  • Proven ability to handle multiple projects and meet deadlines; Demonstrated ability to plan and organize projects.
  • Competent understanding of ISO 9001, ISO 13485, and GMP regulations.
  • Familiar with design control principles and basic inspection techniques.
  • Working knowledge and understanding of the basic principles, theories, concepts, and practices in the applicable area of engineering/technical specialization.
  • Must be able to analyze and resolve non-routine product issues related to installation and service using independent judgment and inspection.
  • Possesses the ability to influence, motivate, and enable others to contribute to the effectiveness of the organization.
  • ASQ &/or RAPS Certifications are a plus
  • Lead Auditor Certification is a plus
  • Lean Six Sigma green or black belt certification is a plus
Responsibilities
  • Works on diverse to complex issues where analysis of situations or data requires an in-depth evaluation of variable factors
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results
  • Determines methods and procedures on new assignments and may coordinate activities of other personnel
  • Evaluates and helps to drive the update to Standard Work, including all service processes, procedures, and systems to improve reliability and repeatability while maintaining compliance to regulatory requirements
  • Collaborates to increase the efficiency of service
  • Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of services and their delivery
  • Investigates and thoroughly understands developments in quality compliance and standards
  • Optimizes Service’s installation processes to efficiently detect defects in early project stages
  • Performs defect analysis utilizing experience in statistical quality process analytical methods
  • Leads the detection and prevention of non-conformances to improve business results in terms of service costs, customer uptime, service vendor and process compliance
  • Partners with Operations to aid in enhancing installation first pass yield and reduce out of box failures
  • Monitors and analyzes service performance trends for key quality metrics and establishes appropriate control measures
  • Coordinates with Operations, R&D, and Regulatory to conduct risk analysis of non-conformances found at installation and drives collaboration and communication for issue resolution through CAPAs, non-conforming material risk analysis, design verification and validations
  • Reviews returned material from installation and verifies non-conformances through root cause analysis; develops and executes action plan to address discrepancies; communicates with the manufacturer as required
  • Facilitates resolution of MRB issues leading to reduction in number of parts and components used in the provision of service
  • Performs statistical analysis to assess the cost of, and determine the responsibility for parts and components that do not meet required standards and specifications
  • Supports product field action initiatives
  • Prepares and maintains a variety of reports; data trending; manages documentation control systems
  • Leads external and internal quality audits
  • Conducts quality audits and evaluations
  • Communicates and resolves QC issues with Field Service on a day-to-day basis
  • Participates in the selection of install/service vendors for the Division
  • Coordinates improvement efforts with vendor discrepancies
  • Prioritizes and manages multiple projects within design specifications and budget restrictions
  • May lead division wide quality initiatives
  • Using data, verify that process and system improvements have increased efficiency and driven down costs
  • Has responsibility for the monitoring and oversight of services implementation and adherence to our quality systems
  • Other duties as assigned by manager
Desired Qualifications
  • ASQ Certification and/or Regulatory Affairs Professionals Society (RAPS) Certifications are a plus
  • Lead Auditor Certification is a plus
  • Lean Six Sigma green or black belt certification is a plus

Hologic develops medical technology to improve health through early detection and treatment. It designs, manufactures, and sells devices and diagnostic tests for breast and skeletal health, general diagnostics, GYN surgery, and medical aesthetics, sold to hospitals, labs, and providers with related services. Products enable screening, imaging, and guiding treatment in clinical settings. Its goal is to improve health outcomes by providing accurate diagnostics and reliable tools to support healthcare providers worldwide.

Company Size

5,001-10,000

Company Stage

IPO

Headquarters

Santa Clara, null

Founded

1985

Simplify Jobs

Simplify's Take

What believers are saying

  • GYN Surgical revenues grew 7.5% to $180.8M in Q1 2026 from MyoSure and Fluent.
  • $18.3B Blackstone-TPG acquisition in April 2026 funds AI and oncology R&D.
  • 3DQuorum AI reduces mammography slices while maintaining diagnostic accuracy.

What critics are saying

  • Blackstone-TPG cuts R&D to service debt, stalling AI mammography within 12 months.
  • CEO MacMillan retires post-April 2026 deal, disrupting GYN surgical integration.
  • US-China tariffs slash Asia-Pacific ThinPrep revenues by 2.7% in Q1 2026.

What makes Hologic unique

  • Hologic leads women's health with ThinPrep Pap test and Aptima HPV assays.
  • Genius AI Detection identifies 90% of invasive lobular breast cancers.
  • Sonata System from 2025 Gynesonics acquisition treats uterine fibroids ultrasonically.

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Benefits

Health Insurance

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Performance Bonus

Company News

Hologic
Apr 20th, 2026
New evidence backs Hologic's ai-powered mammography technology for detecting challenging cancers.

New evidence backs Hologic's ai-powered mammography technology for detecting challenging cancers. Results highlight AI's potential to aid radiologists in identifying diverse breast cancer subtypes, including invasive lobular cancer MARLBOROUGH, Mass., April 20, 2026 - New research on Hologic's AI-driven breast cancer detection technologies, including a study focused on invasive lobular cancer, was presented at the Society of Breast Imaging (SBI) Symposium over the weekend in Seattle, Washington. "Invasive lobular cancers are more challenging to detect on a mammogram because of their unique characteristics," said Mark Horvath, President of Breast & Skeletal Health Solutions at Hologic. "In the study, AI maintained high sensitivity for flagging these cancers, including some that had been interpreted as negative at a prior screening. These data add to a growing body of evidence that AI can act as a powerful supportive tool for radiologists as they review the full spectrum of breast cancers." In this retrospective, single-center study, researchers at Massachusetts General Hospital in Boston reviewed invasive lobular cancer cases diagnosed over a 10-year period and grouped them into two categories: those detected by a radiologist during a routine screening exam (195 total) and "false negatives" that were diagnosed within a year of a routine screening exam initially interpreted as negative (44 total). Researchers then used Hologic's Genius AI(R) Detection solution to retrospectively analyze all 239 cases. In this cohort, the technology identified and correctly localized close to 90% of the confirmed invasive lobular cancers.[1] New research suggests that, on average, 1 in 20 women worldwide will be diagnosed with breast cancer in their lifetime and, that if current rates continue, by 2050 there will be 3.2 million new breast cancer cases and 1.1 million breast cancer-related deaths per year.[2] About 10-15% of all breast cancers are invasive lobular cancers,[3] while ductal cancers that originate in the milk ducts of the breast - such as invasive ductal carcinoma and ductal carcinoma in situ - occur more commonly. Invasive lobular cancer arises in the milk-producing glands (lobules) of the breast and, because of its unique biology and tendency to grow in a linear pattern, it may be more challenging to see on mammography. This may lead to later detection and a more advanced stage at diagnosis. The AI algorithm also identified 43% of the invasive lobular cancer cases initially interpreted during routine screening as negative.[1] Of note, as a retrospective analysis at a single institution, the study did not evaluate how use of AI in real time clinical practice would affect recall rates, biopsy outcomes or patient management. Also at the Society of Breast Imaging Symposium, Hologic hosted a lunch and learn discussion with breast imaging experts focused on implementation of 3DQuorum(R) imaging technology, which uses AI to reduce the number of 3D imaging "slices" radiologists need to review without compromising image quality, sensitivity or accuracy.[4,5] Study Limitations The MGH study did not assess false-positive rates, recall rates or biopsy outcomes, and its single-center design may limit generalizability. AI performance was evaluated retrospectively and did not influence real-time radiologist decision-making; therefore, the observed gains represent a theoretical upper bound rather than a measured clinical impact. Additionally, the cohort included only patients with invasive lobular cancer, precluding comparison with other histologic subtypes. About Genius AI Detection Hologic's Genius AI Detection solution is an innovative mammography screening technology designed to locate lesions likely to represent breast cancer. Suspicious areas are highlighted at radiologists' workstations for concurrent reading to support smart, decisive interpretation. Hologic's deep learning algorithm is fed by the accumulation of a large, diverse patient base, providing rich insight and intelligence. For more information, please visit Genius AI Detection Technology. About Hologic, Inc. Hologic, Inc. is a global leader in women's health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with Hologic Inc. on LinkedIn, Facebook, X, Instagram and YouTube. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. Hologic, The Science of Sure, Genius AI and 3DQuorum are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. Media Contact: Bridget Perry Senior Director, Corporate Communications (+1) 508.263.8654 [email protected]&

Yahoo Finance
Apr 7th, 2026
Hologic delivers weakest Q4 among imaging and diagnostics stocks with revenue miss

GE HealthCare delivered the strongest fourth-quarter performance among medical devices and imaging stocks, whilst Hologic posted the weakest results against analyst estimates, according to a sector review. The four medical devices and imaging companies tracked reported slower fourth-quarter growth overall, though revenues collectively beat consensus estimates by 3.5%. Share prices have struggled since results, falling an average of 13.5%. Hologic, which develops diagnostic products and medical imaging systems focused on women's health, reported revenues of $1.05 billion, up 2.5% year on year but missing analysts' expectations by 2.1%. The company significantly missed both revenue and earnings estimates. Despite the disappointing results, Hologic shares have risen 1.4% since reporting and currently trade at $76.05. GE HealthCare, spun off from General Electric in 2023, outperformed peers in the quarter.

MedTech Dive
Apr 6th, 2026
Hologic CEO Steve MacMillan to retire after go-private deal.

Hologic CEO Steve MacMillan to retire after go-private deal. The $18.3 billion acquisition by Blackstone and TPG is expected to close Tuesday. Published April 6, 2026 Dive brief: * Hologic CEO Steve MacMillan will retire after the company is acquired by funds managed by Blackstone and TPG. * The go-private deal, announced in October, values the maker of mammography machines, cervical cancer screening tests and other diagnostics tools at $18.3 billion. * Hologic said Monday that it has received all needed regulatory approvals for the transaction and expects the acquisition to close Tuesday. Hologic plans to name its next CEO when the acquisition closes. Dive insight: MacMillan, 62, has been CEO of the firm since 2013. During his time at the company, Hologic's revenue increased by 65%, its share price more than tripled, and its workforce grew by more than 1,500 people. Hologic reported $3.26 billion in revenue in its 2025 fiscal year ending in September. Amy Wendell, Hologic's lead independent director, said in a statement that MacMillan "forged a dramatic turnaround shortly after joining the Company, led us through years of consistent growth, drove our unprecedented response to the COVID pandemic, and is guiding us through a successful go-private transaction." Prior to working for Hologic, MacMillan was CEO of Stryker, and held senior executive roles at Pharmacia and Johnson & Johnson. With the take-private agreement by Blackstone and TPG, Hologic's stockholders would receive $76 per share, and up to $3 per share more if the company meets certain revenue goals for its breast health business in fiscal years 2026 and 2027. Hologic will be delisted from the Nasdaq after the deal closes. The company will keep its current headquarters in Marlborough, Massachusetts.

AktienSensor
Mar 31st, 2026
Hologic secures record-low debt financing to boost growth and innovation

Hologic has completed a debt financing package featuring reportedly record-low borrowing costs, among the tightest spreads for leveraged loans in the past decade. The medical technology company structured the deal as a senior secured leveraged-loan facility, though exact figures were not disclosed. The financing aims to reduce debt-service costs, improve cash flow, and provide flexibility for acquisitions and research and development investment. Hologic operates in diagnostic imaging and laboratory testing, competing with Siemens Healthineers and GE Healthcare whilst focusing on precision oncology diagnostics and AI-driven imaging. The deal positions Hologic to pursue strategic partnerships and potential acquisitions in the consolidating medical diagnostics sector, though risks include interest-rate volatility and covenant constraints.

Yahoo Finance
Mar 19th, 2026
Hologic shares trade 1.2% below Blackstone-TPG's $76 buyout offer after shareholder approval

Hologic shares closed at $75.05, trading 1.2% below Blackstone and TPG's $76 per share buyout offer announced in October 2025. The deal includes a contingent value right worth up to $3 per share, tied to Breast Health revenue targets, for a total potential value of $79 per share. Shareholders approved the take-private transaction at a February meeting. The Massachusetts-based medical technology company, which develops diagnostic and imaging products for women's health, has gained 0.7% year-to-date, outperforming peers GE HealthCare and Becton Dickinson. However, Hologic's valuation appears stretched at 3.84 times forward price-to-sales, above its sector average of 2.28 times. First-quarter fiscal 2026 results showed weakness in its Diagnostics division, with revenues declining 2.7% in constant currency.