Senior Life Science Quality Assurance Lead

CooperCompanies; Livingston (NJ); On-site; USD 90,000 - 115,000; Full time

Job summary

CooperSurgical is seeking a Quality Assurance Specialist II in Livingston, NJ to uphold regulatory compliance and drive continuous improvement within the Quality Management System.

You will own document control, change management, deviations, supplier quality, validations, and quality metrics while collaborating with cross‑functional teams to ensure timely root‑cause investigations and effective corrective actions.

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• Experience in QA roles with knowledge of regulatory requirements.
• Familiarity with quality tools and documentation practices.

Responsibilities

• Maintain a culture of quality awareness and cooperate with Quality customers.
• Provide QA oversight and engagement as needed by Operations.
• Own QMS processes: Document Control, Change Management, Deviations/Nonconformances.
• Oversee supplier qualification, quality agreements, and scorecards.
• Review and approve validations and equipment/system qualifications.
• Perform trending and reporting of quality metrics and risk analysis.
• Facilitate meetings, communicate status, and close aging items.
• Develop and deliver training for QMS processes.

Skills

Quality principles knowledge

Statistical methods familiarity

Documentation review experience

Education

Bachelor’s degree in science or related field

Associate degree with 4–6 years related experience

Equivalent combination of education and experience

Tools

MasterControl / eQMS

MS Office (Word, Excel, PowerPoint)

Quality systems knowledge

Job description

CooperSurgical is seeking a Quality Assurance Specialist II in Livingston, NJ to uphold regulatory compliance and drive continuous improvement within the Quality Management System.

You will own document control, change management, deviations, supplier quality, validations, and quality metrics while collaborating with cross‑functional teams to ensure timely root‑cause investigations and effective corrective actions.