Hologic, Inc. · 4 hours ago
Sr. Quality Assurance Engineer
Newark, DE
Full-time
Onsite
Mid, Senior Level
$94K/yr - $147K/yr
1+ years expHologic, Inc. is a company focused on ensuring excellence in manufacturing and production processes. They are seeking a Senior Quality Assurance Engineer to design and maintain quality assurance protocols and collaborate with teams to drive continuous improvement.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Designing, implementing, and maintaining quality assurance protocols that meet internal and external regulatory standards for worldwide distribution
Collaborate with cross-functional teams
Lead quality initiatives
Drive continuous improvement to ensure the delivery of high-quality, innovative products that improve lives globally
Qualification
Required
In-depth understanding of quality management systems (QMS) and regulatory standards (e.g., GMP, GLP, ISO, FDA, Six Sigma)
Strong knowledge of manufacturing, sterilization, and cleanroom processes
Familiarity with quality assurance methodologies such as Root Cause Analysis, Lean, Total Quality Management (TQM), and Statistical Process Control (SPC)
Solid foundation in microbiology, molecular biology, biochemistry, chemistry, or related scientific disciplines
Expertise in nucleic acid amplification, detection technologies, and the scientific method for data analysis
Advanced technical writing and documentation skills to author quality assurance reports, procedures, and investigation protocols
Excellent electrical failure troubleshooting
Strong analytical skills for evaluating large datasets, identifying trends, and drawing valid scientific conclusions
Proficient in quality improvement tools such as CAPA, HRA, HHE, MRB, and SCAR processes
Excellent project management skills with the ability to plan, prioritize, and execute multiple projects within deadlines
Proficiency with computer tools, including word processing, spreadsheets, and databases
Strong interpersonal and collaboration skills to work effectively with cross-functional teams, mentor junior engineers, and present findings to stakeholders
Collaborative and team-oriented, with a commitment to working closely with stakeholders to understand their needs
Detail-oriented and meticulous in ensuring data accuracy and integrity
Proactive in identifying opportunities for innovation and continuous improvement in dashboard design and data analysis processes
Resilient and adaptable in managing challenges in a fast-paced, regulated environment
Demonstrates urgency and accountability in resolving quality issues and ensuring compliance
Bachelor's Degree in Electrical Engineering (preferred) with 2-5 years of experience, or Master's Degree with 1-3 years of experience, or PhD with 0-1 year of experience
Experience in troubleshooting electrical failures (PCB's, cable wire harness assemblies, microchips)
Demonstrated experience in quality assurance, quality improvement methodologies, and regulatory compliance
Proven ability to lead moderate to complex quality projects, including risk management, defect investigations, and corrective actions
Preferred
Experience with sterilization and cleanroom processes is highly beneficial
Certified Quality Engineer (CQE) certification is a plus
Working knowledge of FDA and ISO regulations governing medical devices is highly beneficial
Benefits
Comprehensive training when you join as well as continued development and training throughout your career
Bonus eligible
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
Company data provided by crunchbase