Hologic, Inc. · 1 day ago
Product Quality Engineer II
Newark, DE, United States
Full-time
Onsite
Entry, Mid Level
$78K/yr - $122K/yr
2+ years expHologic, Inc. is seeking a Product Quality Engineer II to ensure the quality and reliability of life-saving medical devices. In this role, you will lead complaint investigations, perform root cause analyses, and implement corrective actions to improve product quality and compliance while collaborating with cross-functional teams.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Lead complaint investigations and perform root cause analyses
Implement corrective and preventive actions to improve product quality and compliance
Drive process improvements and assess risks
Deliver impactful solutions that enhance patient safety and customer satisfaction
Qualification
Required
Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU Medical Device Regulation, ISO 14971 (Risk Management), GMP, and GDP
Familiarity with root cause analysis tools, risk management principles, and compliance frameworks
Proven ability to lead complaint investigations, root cause analyses, and CAPA activities to resolve quality issues
Strong data analysis and trending skills to identify risks, assess failure modes, and recommend mitigations
Effective communication and presentation skills to articulate findings, root causes, and recommendations to stakeholders and leadership
Ability to assess product changes for design and risk management impact, ensuring compliance and quality standards are maintained
Proficiency in developing or improving testing methods for complaint investigations and technical activities
Experience collaborating with cross-functional teams, including Operations, R&D, and Engineering, to drive product and process improvements
Bachelor's degree in Engineering (Mechanical, Biomedical, Biomechanical, Electrical, or related discipline) required
2–5 years of experience in quality engineering, product development, or R&D, preferably in an FDA-regulated industry
Hands-on experience in complaint investigations, root cause analysis, and CAPA activities
Familiarity with internal and external audits, including Notified Body and FDA inspections
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, driving process optimization and identifying opportunities to enhance product quality
Preferred
Preferred knowledge of test method validation, statistical methods, design of experiments (DOE), and industry standards related to reliability, sterilization, packaging, and biocompatibility
Preferred: Familiarity with verification and validation requirements and the development of testable and measurable specifications
Benefits
Comprehensive training when you join as well as 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
2026-01-08
2026-01-07
Company data provided by crunchbase