Sr. Engineer, Post Market Surveillance

LeMaitre Vascular•Burlington, MA

10d

About The Position

Oversees and leads activities associated with complaint handling and regulatory reporting submissions. Responsible for the oversight, management and direct support of investigational tasks required for complaint processing through to closure. Partner with Engineering, Manufacturing, Marketing, Sales, Customer Support, and other functional experts as needed to ensure a clear understanding and an investigation of applicable issues.

Requirements

Bachelors’ degree required.
Degree in Engineering, Microbiology, Biology, Biomedical Engineering, or equivalent field required preferred
2 years’ experience in Medical Devices or related industry.
3 years’ experience managing complaints.
1 year experience independent post market regulatory reporting experience (MDR and/or Vigilance), drafting and submissions.
Competency in at least two of the following areas; CAPAs, NCMRs, Validations, Audit, Design Control, Complaints, or Product Testing.
Microsoft Office.

Responsibilities

Processes complaints and regulatory (MDR, Vigilance, other) reports to ensure that complaints are documented, reviewed, evaluated, investigated, and formally closed in a timely manner.
Interfaces directly with internal and external customers and regulatory agencies as required.
Prepares and contributes responses to regulatory inquiries as needed.
Supports quality metrics development and monitoring, participating in regular business and quality system performance reviews.
Reviews complaint data and prepares reports for internal customers as needed.
Provides support for other Quality functions as needed, including field actions, corrective actions, and others.
Adheres to company policies, procedures, and documentation requirements.
Treats others with courtesy, sensitivity, and respect at all times.
Other duties as assigned.
Sets goals and provides clear direction.
Provides training, coaching, feedback, and recognition.
Responds to employees’ needs and questions as needed.
Supports employee’s career goals and development.
Communicates updates to your employees in a timely manner.
Addresses employee concerns immediately.
Addresses performance and behavior issues appropriately.