Senior Quality Engineer

At Hologic, we are committed to delivering safe, reliable, and innovative diagnostic solutions that improve lives every day. We’re looking for a Senior Quality Engineer – Quality Technical Investigations (QTI) to act as a senior technical expert and mentor, leading complex investigations into product complaints and post‑market signals for our electromechanical IVD devices.

In this role, you will own root cause analysis and closed‑loop corrective actions, drive market‑driven design and process improvements, and ensure that sustaining engineering documentation remains accurate and audit‑ready. You’ll collaborate closely with R&D and cross‑functional teams to enhance product reliability, manufacturability, and serviceability—while coaching junior engineers and championing a world‑class customer experience through systemic, data‑driven improvements. If you thrive on solving complex field issues and turning data into durable product improvements, this role is for you.

• Advanced knowledge of complaint investigations, root cause analysis, and sustaining engineering for complex electromechanical/IVD devices.
• Strong understanding of Quality Management Systems (QMS), CAPA processes, and applicable regulatory requirements such as ISO 13485 and FDA QMSR.
• Deep familiarity with reliability and systems engineering principles and their application to post‑market product performance.
• Awareness of lean/continuous improvement methodologies such as 5S (preferred).
• Preferred: ASQ certifications such as Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) or similar.

• Proven ability to lead complex root cause investigations of product complaints and post‑market signals, applying advanced reliability and systems engineering tools.
• Skilled in driving and implementing significant process and design changes that reduce field failures and improve durability and serviceability.
• Competent in ensuring sustaining engineering documentation is current, accurate, and compliant with regulatory and audit requirements.
• Strong capability to lead cross‑functional teams, translating quality feedback into robust, manufacturable, and serviceable product improvements.
• Ownership of closed‑loop corrective actions, ensuring systemic changes that prevent recurrence of quality issues.
• Superior analytical, problem‑solving, and documentation skills, including preparation and review of audit and regulatory support documentation.
• Proven experience mentoring, coaching, and providing technical leadership to other engineers and team members.
• Excellent communication and collaboration skills, with the ability to influence and align stakeholders across functions.

• Lead with Ownership:
  Demonstrates accountability and integrity in all actions, taking responsibility for investigation outcomes and improvements.
• Act with Speed:
  Drives timely, effective solutions and keeps stakeholders informed with clear, proactive communication.
• Foster Partnerships:
  Builds strong, collaborative relationships across Quality, R&D, Operations, Service, and other functions.
• Delight Customers:
  Champions innovative, customer‑centered improvements that enhance field performance and user experience.
• Celebrate Wins:
  Recognizes impactful results, supports team members, and contributes to a positive, high‑performance culture.
• Promotes a culture of continuous improvement, process focus, and respect within the team and across the organization.

• Bachelor’s degree in engineering or a related technical field required. Software degree preferred.
• Advanced degree preferred.
• 8 years of experience in quality, reliability, or systems engineering within the medical device or related regulated industry.
• Demonstrated success leading cross‑functional improvement initiatives and complex investigations.
• Experience supporting regulatory audits and maintaining audit‑ready documentation.

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 $97,600-$152,700 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.