Quality Manager: Product & Client Excellence

Regulatory Toolkit; Ridgefield (NJ); On-site; USD 114,000 - 170,000; Full time

Benefits offered by this job

Medical and dental plans

Vision plan

PTO 120 hours + holidays

Parental leave

Commuter benefits

Tuition reimbursement

401(k) plan

Employee stock purchase plan

Job summary

Thermo Fisher Scientific in New Jersey is seeking a Quality Manager to oversee our quality management system and drive regulatory compliance and patient safety. You will guide CAPAs, manage APQRs and management reviews, and collaborate with Manufacturing, Regulatory Affairs, and Supply Chain to resolve quality issues and foster continuous improvement.

This role requires a Bachelor's degree plus 4–5 years in quality within pharma/medical devices, ISO 9001/13485 knowledge, and ability to mentor

Qualifications

• Bachelor's Degree with 4-5 years of quality experience in pharma, medical devices, or regulated industry.
• Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP).
• Experience supporting internal/external audits and regulatory inspections.
• Demonstrated ability to develop and mentor quality teams.
• Proven track record implementing and improving quality systems.

Responsibilities

• Plan and deliver Annual Product Quality Reviews (APRs) on schedule.
• Coordinate management review presentations with subject matter experts.
• Author and manage reports, decisions, and actions from APQRs and reviews.
• Support site Change controls, CAPAs and Deviations as needed.
• Support site Quality Plan and track KPIs & metrics with stakeholders.
• Lead QMS improvements and cross-functional process optimization.

Skills

CAPA

Risk analysis

FMEA

Root cause analysis

Auditing

Education

Bachelor's Degree in a scientific/technical field

Tools

TrackWise

Document Control Systems

Job description

Thermo Fisher Scientific in New Jersey is seeking a Quality Manager to oversee our quality management system and drive regulatory compliance and patient safety. You will guide CAPAs, manage APQRs and management reviews, and collaborate with Manufacturing, Regulatory Affairs, and Supply Chain to resolve quality issues and foster continuous improvement.

This role requires a Bachelor's degree plus 4–5 years in quality within pharma/medical devices, ISO 9001/13485 knowledge, and ability to mentor