Sr Quality Systems Specialist

Hologic•Newark, NJ

4d•$85,200 - $133,300

About The Position

Hologic is seeking a Senior Quality Systems Specialist to strengthen and sustain our Quality Management System (QMS) and quality operations. In this role, you’ll 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. You’ll use data-driven tools to analyze trends, support continuous improvement, and ensure our systems are audit-ready. If you enjoy solving diverse quality challenges, partnering cross-functionally, and owning impactful quality system initiatives in a regulated environment, this role is a strong fit. Knowledge 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. Beneficial: Basic understanding of statistics and statistical analysis for quality metrics and KPIs. Beneficial: Experience with Agile or equivalent PLM systems. Skills 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. Behaviors 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.

Requirements

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.

Nice To Haves

Basic understanding of statistics and statistical analysis for quality metrics and KPIs.
Experience with Agile or equivalent PLM systems.
Experience supporting internal and external audits and/or FDA inspections is beneficial.