Integra LifeSciences · 5 months ago
Specialist, Quality Compliance
US-NJ-Plainsboro-105-Facility
Full-time
Onsite
Mid Level
3+ years expIntegra LifeSciences is a company focused on innovating new treatment pathways to advance patient outcomes. The Quality Compliance Specialist will provide quality compliance support to the Collagen Manufacturing Center, ensuring adherence to various regulatory standards and participating in quality system documentation development and approval.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Review and approve quality documents requiring QA oversight (e.g., IOPQ and validation protocols, Engineering Change Orders (ECO), deviations, OOS/OOT reports, DHR, Supplier Quality Assessments, Supplier Corrective Action Reports (SCAR), alert and action reports, purchasing specifications, etc.)
Prepare and compile metrics for Quality Management Reviews
Serve as the quality compliance representative for project teams
Participate on new product development project teams as quality compliance representative
Support investigation of complaints, nonconforming raw materials, in-process product or finished goods as necessary
Provide guidance for Product Development, Operations and Engineering teams on project development activities to ensure they conform to internal SOPs
Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs
Review product and process changes for impact on existing notification requirements, for conformance with Design Control regulations and standards, and internal Standard Operating Procedures
Provide support in FDA inspections, ISO audits and customer audits at the CMC facility
Qualification
Required
Bachelor's degree or higher in scientific, or related field
3- 5 years experience in Quality
Excellent oral, written and presentation communication skills are required
High degree of attention to details and organization skills are required
Must possess a team-focused attitude
Demonstrated computer skills
Ability to work independently
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase