Hologic, Inc. · 2 weeks ago
Senior Product Quality Engineer
Marlborough, MA
Full-time
Onsite
Mid, Senior Level
$98K/yr - $153K/yr
5+ years expHologic, Inc. is seeking a Senior Product Quality Engineer to ensure the quality and reliability of life-saving medical devices. The role involves leading complaint investigations, performing root cause analyses, and implementing corrective actions to enhance product performance while collaborating with cross-functional teams to ensure regulatory compliance and improve patient safety.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead complaint investigations, perform root cause analyses, and drive the implementation of corrective and preventive actions to improve product performance
Collaborate with cross-functional teams to contribute to product design, process improvements, and regulatory compliance
Qualification
Required
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
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
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
Preferred
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
Experience in an FDA-regulated industry preferred
Hands-on experience in root cause analysis, complaint investigations, and product development or R&D is beneficial
Benefits
Comprehensive training when you join
Continued development and training throughout your career
Company
Hologic, Inc.
We’re an innovative medical technology company whose purpose is to enable healthier lives everywhere, every day.
5001-10000 employees
H1B Sponsorship
Hologic, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (31)
2024 (20)
2023 (15)
2022 (32)
2021 (20)
2020 (14)
Funding
Current Stage
Public CompanyTotal Funding
$2.87B2025-10-21Private Equity
2025-10-21Acquired
2025-07-15Post Ipo Debt· $2.42B
Leadership Team
Stephen MacMillan
Chairman President & CEO
Karen Harrington
Director Scientific Affairs
Recent News
2026-01-17
2026-01-17
Company data provided by crunchbase