Quality Engineer 2
About The Position
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!
Requirements
- 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.
- 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.
- 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.
Nice To Haves
- Knowledge of ASQ certifications (CQE, CRE) and other quality/reliability standards.
- Experience with lean methodologies and statistical tools for continuous improvement.
- Experience with lean/continuous improvement methodologies such as 5S.
- ASQ Certified Quality Engineer (CQE), ASQ Certified Reliability Engineer (CRE), or similar certification.
Responsibilities
- Lead root cause analysis
- Resolve product complaints
- Drive post-market improvements for electromechanical in vitro diagnostic (IVD) devices
- Collaborate with design, manufacturing, and service teams to translate customer feedback into actionable solutions that enhance product reliability, durability, and serviceability
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
Number of Employees
5,001-10,000 employees
