Senior Post-Market Surveillance Engineer

LeMaitre Vascular; Burlington (MA); On-site; USD 120,000 - 140,000; Full time

Job summary

LeMaitre Vascular is seeking a Quality Compliance professional to oversee complaint handling and regulatory reporting submissions. You will manage investigational tasks needed for complaint processing through closure and partner with Engineering, Manufacturing, Marketing, Sales, Customer Support and others to ensure clear issue understanding and thorough investigations.

The role requires a Bachelor's degree in a relevant field and multiple years in medical device quality/regulatory work,

Qualifications

• Bachelors degree in Engineering, Microbiology, Biology, Biomedical Engineering or equivalent required.
• Minimum 2 years of experience in Medical Devices or related industry.
• Minimum 3 years managing complaints.
• Minimum 1 year experience in independent post market regulatory reporting (MDR and/or Vigilance).
• Competency in CAPAs, NCMRs, Validations, Audit, Design Control, Complaints, or Product Testing.

Responsibilities

• Processes complaints and regulatory reports to ensure documentation, review, evaluation, investigation and formal closure.
• Interfaces with internal/external customers and regulatory agencies as required.
• Prepares responses to regulatory inquiries as needed.
• Supports quality metrics development and monitoring and participates in reviews.
• Reviews complaint data and prepares internal reports.
• Provides support for other Quality functions, including field actions and corrective actions.
• Adheres to company policies and documentation requirements.
• Treats others with courtesy, respect, and professionalism.
• Other duties as assigned.

Skills

CAPAs

NCMRs

Validations

Audit

Design Control

Complaints

Product Testing

Microsoft Office

Education

Bachelor's degree in Engineering, Microbiology, Biology, Biomedical Engineering or equivalent

Job description

LeMaitre Vascular is seeking a Quality Compliance professional to oversee complaint handling and regulatory reporting submissions. You will manage investigational tasks needed for complaint processing through closure and partner with Engineering, Manufacturing, Marketing, Sales, Customer Support and others to ensure clear issue understanding and thorough investigations.

The role requires a Bachelor's degree in a relevant field and multiple years in medical device quality/regulatory work,