Hologic

Are you ready to play a critical role in ensuring the reliability and quality of life-saving medical devices? At Hologic, we are seeking a Quality Engineer II – Quality Technical Investigations (QTI) to lead root cause analysis, resolve product complaints, and drive post-market improvements for electromechanical in vitro diagnostic (IVD) devices. In this role, you’ll collaborate with design, manufacturing, and service teams to translate customer feedback into actionable solutions that enhance product reliability, durability, and serviceability. If you’re passionate about problem-solving, quality engineering, and delivering meaningful outcomes that improve the customer experience, we encourage you to apply!

Knowledge:

• Expertise in complaint investigations, root cause analysis, and sustaining engineering for medical devices.
• Strong understanding of Quality Management Systems (QMS), CAPA processes, and regulatory requirements, including ISO 13485 and FDA QMSR.
• Familiarity with reliability and systems engineering principles.
• Awareness of post-market surveillance and continuous improvement methodologies, such as 5S.
• Preferred: Knowledge of ASQ certifications (CQE, CRE) and other quality/reliability standards.

Skills:

• Proven ability to lead root cause investigations and drive resolution of systemic quality issues through closed-loop improvement.
• Strong analytical skills for identifying trends, evaluating data, and developing actionable solutions.
• Effective communication skills to collaborate with cross-functional teams and present findings to stakeholders.
• Exceptional organizational and documentation skills to maintain audit-ready records and compliance documentation.
• Ability to implement process and design improvements that reduce field failures and enhance serviceability.
• Commitment to customer-focused solutions, ensuring product reliability and satisfaction.
• Preferred: Experience with lean methodologies and statistical tools for continuous improvement.

Behaviors:

• Ownership-driven, taking responsibility for deliverables and outcomes with a proactive attitude.
• Speed-focused, addressing issues promptly and sharing findings clearly and effectively.
• Collaborative and partnership-oriented, fostering productive relationships across teams.
• Customer-focused, committed to improving product reliability and elevating the customer experience.
• Continuous improvement mindset, leveraging feedback and data to optimize processes and drive impactful changes.
• Detail-oriented and organized, ensuring thoroughness and accuracy in all documentation and investigations.

Experience:

• Bachelor’s degree in engineering or a related technical field.
• 2–4 years of experience in quality, reliability, or systems engineering within the medical device or related regulated industry.
• Hands-on experience with complaint investigations, CAPA processes, and sustaining engineering.
• Proven track record of supporting regulatory audits and maintaining audit-ready documentation.
• Preferred: Experience with lean/continuous improvement methodologies such as 5S.
• Preferred: ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), or similar certification.

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 $78,000-$122,100 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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