Integra LifeSciences · 2 weeks ago
Senior Quality Engineer I - Validations, Risk Management & Statistics
Plainsboro, NJ
Full-time
Onsite
Mid, Senior Level
$82K/yr - $113K/yr
6+ years expIntegra LifeSciences is a company dedicated to changing lives and building careers in the healthcare sector. They are seeking a Senior Quality Engineer I to provide compliance support for quality tasks, assist in launching new products, and ensure adherence to regulatory standards in the manufacturing of medical devices.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
Assists in the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective
Providing guidance on the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects
Participate in the execution of Process FMEA and other applicable risk analysis documentation as deemed appropriate
Develop statistically based sampling plans for in-process and finished goods testing, inspections, validations and where required. Provide Statistical Analysis of the data to support all Quality Systems documentation such as validations, NCs, Complaints, etc
Develop, review and approve validations and completion reports for new and existing products, processes and equipment
Prepare monthly and quarterly trending, including Statistical Process Control documentation, and support the Quality Management Review Process
Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements
Participate in FDA inspections, ISO Certification and surveillance audits and customer audits
Perform other Quality Assurance and Quality Engineering related duties as required
Qualification
Required
Bachelor's Degree in engineering preferred (Biomedical, mechanical, chemical, or electrical) or Science (Biology)
6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing
Demonstrates knowledge of statistical sampling and analysis
Demonstrates excellent organizational, communication, and project management skills
Proficient with the MS Office Suite, and statistical software
Must be able to work independently with minimal supervision
Able to prioritize projects to meet organizational goals and objectives
Preferred
ASQ CQE preferred
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
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