Sr Quality Systems Specialist

Mary Dickson; Newark (DE); On-site; USD 85,200 - 133,300; Full time

Job summary

Hologic is seeking a Senior Quality Systems Specialist in Newark, DE to enhance our Quality Management System (QMS) and lead quality operations. You will work collaboratively across engineering and supply chain to tackle quality challenges and ensure systems are audit-ready.

The ideal candidate should possess a Technical Bachelor’s Degree and relevant experience in QMS, particularly in a regulated medical device environment. Compensation is competitive, with an annual salary range of $85,200–$133,300 plus bonuses.

Qualifications

• 3–5 years of experience in the medical device or IVD industry without a technical degree.
• 2–4 years of experience with a technical Bachelor’s degree, 1–3 years with a Master’s degree.
• Hands-on experience with QMS elements like Management Review and audits.

Responsibilities

• Strengthen and sustain the Quality Management System (QMS).
• Investigate process, product, and system issues.
• Support audits and inspections.

Skills

Excellent computer skills

Strong technical writing skills

Auditing knowledge

Experience with Quality Management Systems

Interpersonal skills

Education

Technical Bachelor’s Degree (Engineering, Life Sciences)

Job description

Senior Quality Systems Specialist

Newark, DE, United States Marlborough, MA, United States

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 ISO13485, MDSAP, EUMDR, and 21CFR820/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.
• Basic understanding of statistics and statistical analysis for quality metrics and KPIs (beneficial).
• Experience with Agile or equivalent PLM systems (beneficial).

Skills

• Excellent computer skills, including 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.

Experience

• 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.
• 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.

Why join Hologic?

We are committed to making Hologic the destination for top talent. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $85,200–$133,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.