Lead Quality Assurance Coordinator

Company: Integra LifeSciences Corporation
Location: Boston
Posted on: June 2, 2025

Job Description:

Changing lives. Building Careers.Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.Performs the essential duties and responsibilities as listed in section below.

• Review of production activities including completed forms and batch records against procedure requirements and product specifications for material and product release.
• Review of quality monitoring and testing activities including environmental monitoring and product surveillance.
• Supports QA procedure changes including writing, revising, training, and implementation.
• Conducts training for staff at all levels as it relates to quality assurance review and release procedures. Compiles quality metrics for daily/weekly/monthly reporting and reports metrics to site management.
• Compiles information for Quality Management Review.
• Conducts inspections of materials.
• Reviews records for compliance to procedures such as inspection reports, test records, and Device History Records.
• Conducts CAPA investigations, proposes corrective and preventative actions, and conducts verification and effectiveness reviews. Initiates Nonconforming Material reports, conducts nonconformance investigations, and presents reports/metrics during periodic meetings.
• Participates in audits/inspections by customers and regulatory agencies and compiles corrective and preventative action responses.
• Other duties may be assigned as necessary.Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.This site is governed solely by applicable U.S. laws and governmental regulations.
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Keywords: Integra LifeSciences Corporation, Concord , Lead Quality Assurance Coordinator, Other , Boston, New Hampshire