Sr. Engineer, Post Market Surveillance

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

Overview

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.

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.

Management Responsibilities:

• 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.

Pay range 120,000-140,000 per year plus bonus. The range provided is based on what we believe is a reasonable estimate for the base pay range for this job at the time of posting. The actual base salary pay will be based on a number of factors such as education, qualifications, certifications, experience, and other job-related factors permitted by law.

Qualifications

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.

EEO Statement

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at LeMaitre Vascular will be based on merit, qualifications, and abilities. LeMaitre Vascular does not discriminate in employment opportunities or practices on the basis of race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity, breastfeeding or related medical conditions, religious dress, military or veteran status or any other characteristic protected by law.

This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination, and access to benefits and training.