Hologic, Inc. · 3 hours ago
Sr Quality Systems Specialist
Newark, DE, United States
Full-time
Onsite
Mid, Senior Level
$85K/yr - $133K/yr
2+ years expHologic, Inc. is seeking a Senior Quality Systems Specialist to strengthen and sustain their Quality Management System (QMS) and quality operations. The role involves collaborating with various functions to investigate issues, support audits, and develop quality procedures while using data-driven tools for continuous improvement.
BiotechnologyHealth CareHealth DiagnosticsWomen's
Responsibilities
Strengthen and sustain the Quality Management System (QMS) and quality operations
Work across engineering, supply chain, regulatory, marketing, and other functions to investigate process, product, and system issues
Support audits and inspections, and help develop and refine quality procedures
Use data-driven tools to analyze trends and support continuous improvement
Ensure systems are audit-ready
Qualification
Required
Working understanding of Quality Management Systems (QMS), especially Management Review, Quality System audits, CAPA, nonconformances, and quality planning
Knowledge and experience with ISO 13485, MDSAP, EU MDR, and 21 CFR 820/QMSR in a medical device or IVD environment
Familiarity with internal and external audit expectations and documentation needs (front-room/back-room)
Understanding of GMP concepts and quality system processes such as Quality Agreements, Quality Plans (QPLs), and Periodic Review
Excellent computer skills, including use of word processing, spreadsheet, and database applications (data entry, querying, and report generation)
Strong technical writing skills for drafting procedures, quality system documentation, audit responses, and investigation reports
Ability to apply auditing knowledge to help build robust, audit-ready systems and documentation
Experience with Quality Management Systems, particularly Management Review, CAPA, and quality system audits
Capable of documenting technical work and leading/assisting investigations and improvements in a GMP-regulated environment
Able to modify, maintain, and create procedures and processes related to QMS elements
Comfortable presenting materials and quality system status to director-level leadership
Strong interpersonal skills to collaborate with junior staff, peers, and senior stakeholders across the organization
Models Hologic's quality values, promoting defect prevention, reduction of variation and waste, and continuous improvement
Detail-oriented and thorough, ensuring quality records, procedures, and outputs are accurate and compliant
Collaborative and communication-focused, working effectively with cross-functional teams at all levels
Uses sound judgment in selecting methods and techniques to solve diverse quality system problems
Proactive and self-directed, requiring little day-to-day instruction while responding effectively to new assignments
Comfortable networking with senior internal and external personnel within area of expertise
College Degree required; Technical Bachelor's Degree preferred (e.g., Engineering, Life Sciences, or related field). With a non-technical college degree: 3–5 years in the medical device or IVD industry. Or with a technical Bachelor's degree: 2–4 years of experience; 1–3 years with a Master's degree
Experience in a certified medical device or pharmaceutical manufacturing environment
Hands-on experience with QMS elements such as Management Review, audits, CAPA, and quality planning
Experience supporting internal and external audits and/or FDA inspections is beneficial
Preferred
Basic understanding of statistics and statistical analysis for quality metrics and KPIs
Experience with Agile or equivalent PLM systems
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
Company data provided by crunchbase