Senior Product Quality Engineer

Hologic • Marlborough, MA

9d • $97,600 - $152,700

About The Position

Are you passionate about ensuring the quality and reliability of life-saving medical devices? At Hologic, we are seeking a Senior Product Quality Engineer to provide engineering support for on-market medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance. Collaborating with cross-functional teams, you’ll contribute to product design, process improvements, and regulatory compliance while making a meaningful impact on patient safety and satisfaction. If you’re a proactive problem-solver with a strong background in quality engineering, we encourage you to apply!

Requirements

• Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, and ISO 14971 (Risk Management).
• Familiarity with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Knowledge of root cause analysis tools and risk-based decision-making processes.
• Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues and improve product performance.
• Strong data analysis and trending skills to identify patterns, assess risks, and recommend mitigations.
• Ability to manage and implement design or process changes, including testing, documentation, and change control.
• Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership.
• Ability to collaborate with cross-functional teams, including Operations, Engineering, and R&D, to drive improvements in product design and manufacturing processes.
• Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline) required.
• 5+ years of experience with a Bachelor’s degree in Mechanical, Biomedical, Biomechanical, or Electrical Engineering.
• 1–3 years of experience with a Master’s degree, or 0–1 year with a PhD in a related field.
• Experience in an FDA-regulated industry preferred.
• Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial.
• Detail-oriented and compliance-focused, ensuring adherence to regulatory standards and quality system requirements.
• Proactive and results-driven, with a strong sense of ownership for deliverables and outcomes.
• Collaborative and team-oriented, building productive relationships across functions to drive quality improvements.
• Customer-focused, with a commitment to addressing field quality issues and ensuring timely resolution.
• Continuous improvement mindset, actively identifying opportunities to enhance processes and product quality.

Nice To Haves

• Familiarity with test method validation, statistical methods, and standards related to reliability, electrical safety, sterilization, packaging, and biocompatibility.
• Experience with statistical tools, design of experiments (DOE), and verification/validation requirements for regulated products.

Responsibilities

• Lead complaint investigations
• Perform root cause analyses
• Drive the implementation of corrective and preventive actions to improve product performance
• Collaborate with cross-functional teams
• Contribute to product design
• Contribute to process improvements
• Contribute to regulatory compliance

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees