Hologic, Inc.HI

Manager, Compliance Audit Engineering

Hologic, Inc. is a global champion of women's health, developing innovative medical technologies focused on detecting, diagnosing, and treating health conditions.

Hologic, Inc.

Employee count: 5000+

Salary: 120k-199k USD

United States only

This individual will work under the direction of the Director of Compliance and will manage several technical aspects of the Center of Excellence for QARA Audits. The role will manage the overall Corporate and Internal Compliance Audit risk assessment process for the company, the technical audit strategy and will be part of the Corporate Compliance audit team.

Knowledge:

  • In-depth understanding of global medical device regulations, including 21 CFR 820, ISO 13485, EU MDR 17/745, and EU IVDR 17/746.
  • Comprehensive knowledge of risk management principles (ISO 14971) and auditing methodologies (ISO 19011, MDSAP).
  • Expertise in technical documentation, design control processes, and post-market requirements (e.g., vigilance reporting, complaint handling, trending).
  • Familiarity with safety standards for electronics (IEC 60601), metrology and lab standards (ISO 17025), and software development/validation.
  • Advanced proficiency in statistical techniques, including sampling plans, regression analysis, design of experiments, and measurement system analysis.

Skills:

  • Ability to lead complex technical audits, providing expertise in design control, risk management, and statistical techniques.
  • Strong communication skills to convey technical findings and provide training for auditors on compliance-related topics.
  • Advanced problem-solving and analytical skills to evaluate technical risks and recommend corrective actions.
  • Organizational skills to manage corporate audit programs, risk assessments, and cross-functional compliance initiatives.
  • Capability to develop and deliver technical training materials for auditors on topics like product validation, root cause analysis, and statistical methods.

Behaviors:

  • Proactive and solution-oriented mindset to identify compliance gaps and implement improvement strategies.
  • Collaborative approach to working with cross-functional teams and supporting external regulatory audits.
  • High attention to detail and commitment to maintaining the integrity of technical documentation and audit processes.
  • Adaptability to thrive in a dynamic, global environment with frequent travel and evolving regulatory requirements.

Experience:

  • 5-7 years in roles such as Manufacturing, Quality Engineering, R&D, Compliance, Quality Systems, or Regulatory Affairs within the medical device industry.
  • 5-7 years as a Lead Auditor or Technical Auditor, with active certifications (e.g., IRCA, RABQSA, ISO 13485:2016 Lead Auditor, EU MDR/IVDR Auditor).
  • Demonstrated expertise in quality engineering, electrical medical devices, sterilization, and software validation.
  • Experience managing global compliance audit programs and working across diverse regulatory environments.

The individual fulfilling this role must possess the physical capability to sit for extended periods, handle, or manipulate objects, tools, or controls with precision. Additionally, they should be able to stand, walk, reach with hands and arms, stoop, kneel, crouch, and be prepared to engage in domestic and international travel as required by the position.

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.

About the job

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Job type

Full Time

Experience level

Manager

Salary

Salary: 120k-199k USD

Location requirements

Hiring timezones

United States +/- 0 hours

About Hologic, Inc.

Learn more about Hologic, Inc. and their company culture.

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At the heart of what we do at Hologic is a commitment to improving the health and well-being of women around the world. We develop innovative medical technologies that aim to provide effective detection, diagnosis, and treatment of health conditions, raising the standard of care globally. Our dedication to women’s health is more than a business; it is our purpose and passion. We strive to ensure that women feel supported at every stage of life, facing unique health challenges and barriers that prevent them from accessing the care they need.

Our mission is clear: to empower every woman with health options that promote better lives through early detection and proactive treatment. Hologic’s initiatives, like the Global Women’s Health Index, illuminate the critical status of women's health and encourage action to improve policies and access. We understand the importance of community involvement and work tirelessly to foster partnerships that enhance awareness and action to break down the obstacles women encounter globally. With a global presence in over 100 countries and a diverse team of around 7,000 employees, we integrate 'The Science of Sure' into every innovation, ensuring that healthcare professionals and their patients can make informed decisions with confidence.

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Hologic, Inc.

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