Manager, Compliance Audit Engineering

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.

Originally posted on Himalayas