LeMaitre · 1 month ago
Sr. Quality Engineer - North Brunswick NJ facility (Artegraft)
US-NJ-North Burnswick
Full-time
Onsite
Mid, Senior Level
2+ years expLeMaitre is a company focused on improving the product quality of medical devices and ensuring compliance with regulatory requirements. The role involves supporting quality engineering practices, conducting validations, and applying statistical methods for continuous improvement in product quality.
HardwareHealth CareManufacturing
Responsibilities
Own and/or support root cause determinations and execution of corrective actions per Non-Conforming Material Reports (NCMR’s) and Corrective Actions & Preventive Actions (CAPA’s)
Understand, own, and execute risk management practices and files and ensure compliance to applicable standards
Facilitate environmental monitoring and ensure. Understands and executes risk management practices in relation to environmental monitoring and bioburden and relevant excursion
Monitor and provide quality engineering support to team members performing or responsible for calibration
Prepare and execute validations, technical studies, test method validations, and other studies / reports as required. This includes preparation of protocols, establishment of test methodology and acceptance criteria, training personnel, execution, data analysis, investigation, and writing final reports. Analyze and report quality system data, as needed, to the Quality and Manufacturing teams
Applies statistical process control (SPC) methods for analyzing data to evaluate the current process and process changes
Utilize statistical techniques and six sigma tools to analyze processes to drive continuous improvement and/or identify performance changes
Read and interpret standards in the area’s sterilization, bioburden, endotoxins, and relevant product testing for development and modification of procedures and protocols
Qualification
Required
Bachelor's Degree in Microbiology, Biology, Biomedical Engineer, or equivalent field from an accredited four year college or university
2-6 years of equivalent experience in a related field, preferably in Medical Device
Functional understanding of medical device standards ISO 13485, ISO 11138-7, and ISO 14971
Experience in using MS Word, Excel, Power Point and Outlook
Strong oral and written communication skills
Company
LeMaitre
LeMaitre is a provider of devices, implants and services for the treatment of peripheral vascular disease, a condition that affects more than 200 million people worldwide.
501-1000 employees
H1B Sponsorship
LeMaitre 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
2024 (1)
2023 (3)
2022 (1)
2021 (2)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$204.5M2024-12-16Post Ipo Debt· $150M
2021-07-14Post Ipo Equity· $54.5M
2006-10-19IPO
Leadership Team
JJ Pellegrino
Chief Financial Officer and Board Member
Sandi Catino
Human Resources Business Partner
Recent News
2025-11-08
LeMaitre Vascular, Inc.
2025-11-07
2025-11-05
Company data provided by crunchbase