Senior Quality Engineer
About The Position
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.
Requirements
- 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).
- 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.
- 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.
Nice To Haves
- Preferred: ASQ certifications such as Certified Quality Engineer (CQE) or Certified Reliability Engineer (CRE) or similar.
- Advanced degree preferred.
Responsibilities
- Lead complex investigations into product complaints and post‑market signals for our electromechanical IVD devices.
- Own root cause analysis and closed-loop corrective actions
- Drive market-driven design and process improvements
- Ensure that sustaining engineering documentation remains accurate and audit-ready.
- Collaborate closely with R&D and cross-functional teams to enhance product reliability, manufacturability, and serviceability
- Coach junior engineers and champion a world-class customer experience through systemic, data-driven improvements.
Benefits
- comprehensive training when you join as well as continued development and training throughout your career.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
