Quality Systems Specialist

Overview

Remote
On Site
Hybrid
BASED ON EXPERIENCE
Contract - Independent
Contract - W2
Contract - 5+ mo(s)

Skills

QUALITY SYSTEM
MEDICAL DEVICE
MEDICAL DEVICES
CAPA

Job Details

Quality Systems Specialist
6+Month Contract
Remote Position

Responsibilities:

  • Contribute significantly to Corrective and Preventive Action activities, conducting root cause investigations, verification of effectiveness, and trend analysis.
  • Collaborate closely with the Customer Complaint handling team, aiding in investigations and resolution.
  • Engage with cross-functional teams including Customer Service, Service, Repair, R&D, QA, Regulatory Affairs, and Sales to facilitate necessary actions.
  • Conduct Nonconforming Product activities, performing investigations and trend analysis.
  • Execute Internal Audits, External Supplier Audits, and provide overall audit support.
  • Manage Supplier Management Activities.
  • Coordinate U.S. FDA remediation activities to ensure regulatory compliance.
  • Support the preparation of Management Review Meeting presentations.
  • Attend department and company-wide team meetings as required.
  • Other duties as assigned.

Requirements:

  • Bachelor s degree highly preferred.
  • Five (5) or more years of hands-on experience in Quality System support within a U.S. FDA regulated environment.
  • Deep knowledge of U.S. FDA medical device regulations (21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807).
  • Proficient in international medical device standard requirements (ISO 13485/ISO 9001, ISO 14971, EU Medical Device Directive, and Canada Medical Device Regulations).
  • Excellent leadership, communication, collaboration, teamwork, and interpersonal skills.
  • Strong ability to communicate effectively with staff members and business partners at all levels.
  • Excellent computer and internet search skills.
  • Ability to multitask and meet business deadlines effectively.
  • Excellent organizational skills with proactive thinking and prioritization.
  • Physical capabilities including sitting, using hands and fingers, standing, talking, hearing, and lifting up to ten pounds.


Metasys Technologies is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identify, national origin, veteran or disability status.