Quality Systems Coordinator

Contego Medical, LLC Located in: Raleigh,  North Carolina
(Private and Secure - Guaranteed!)

Contego Medical, LLC Biotechnology Jobs Pharmaceutical Careers
 

JOB DESCRIPTION

Coordinates activities related to Company's Quality System. Assists in the creation and implementation of policies and procedures. Requires working experience of quality systems, including, document and change control and understanding of corresponding regulatory requirements per FDA’s QSR and ISO 13485 regulations. It also requires the ability to work with various functions in the company to ensure compliance to document control and change control procedures. 

Key Responsibilities

  • Maintain an effective Quality System
  • Plans, coordinates, and leads QA program associated with the creation and maintenance of GMP-related documents to ensure consistency with established standards
  • Maintains an effective document control system, including routing, review, organizing, filing, and maintaining QMS documents (SOPs, WIs, Forms, etc.) and records and ensures change control compliance with FDA’s QSR and ISO 13485
  • Manages company-wide training program including the coordination of training activities, review, filing, and monitoring company-wide training status.
  • Maintains Audit and Supplier Management Program
  • Manages CAPA process, support root cause analysis and implementation of corrective action
  • Assists in Complaint investigations
  • Other tasks as required or assigned by management

CRITICAL REQUIREMENTS

    • Minimum associates degree in related field
    • 5+ years’ experience in Medical Device Industry
    • Demonstrated understanding of ISO13485, ISO14971, and 21CFR820
    • Well-developed teamwork and collaboration skills and the ability to communicate clearly and professionally both verbally and in writing. 
    • Ability to analyze, understand and effectively communicate QSR/QMS material.
    • Must have prior experience in document control in a regulated work environment.
    • Ability to organize and set priorities in a fast-paced environment and work independently with minimal supervision

COMPANY INFORMATION

Contego Medical, LLC is a medical device company poised to disrupt the field of endovascular medicine. The Company’s Integrated Embolic Protection technology has been uniquely designed to address unmet needs in peripheral and cardiovascular procedures. The core benefit of this platform technology is the integration of embolic protection onto the same catheter as the treatment portion (i.e., balloon or stent). Contego has amassed a team of highly seasoned medical device professionals to manage this effort, led by Founder and CEO Ravish Sachar, MD, FACC. The Company is positioned for growth in a number of target markets and geographies over the next several years.

JOB INFORMATION

Seniority Level:
Experienced - Not Management
Function:
  Quality,  Compliance
Preferred Industry Background:
  Medical Device
Managing a team of:
N/A
Required Travel:
Very Little - 1 week per month

Base Salary:
50,000 To 70,000 USD PER year
Bonus:
Benefits:
Standard
Other Compensation:
Education Required:
Associates Degree
Therapeutic Experience:
Cardiovascular
Class of Device:
Class 2