Senior Quality Systems Leader - QMS Expert

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

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.