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Quality Assurance Specialist

2 months ago

Reston, Virginia, United States Barrington James Full time
Job Summary

Barrington James is seeking a highly skilled and detail-oriented Medical Device Quality Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring that all medical devices meet rigorous quality, safety, and regulatory standards.

Key Responsibilities
  • Verification and Validation (V&V):
  • Develop and implement verification and validation strategies for medical device projects in a regulated environment.
  • Ensure V&V activities comply with internal quality requirements and relevant regulatory standards, including ISO 13485, FDA 21 CFR 820, and ISO 14971.
  • Design and execute test plans, protocols, and traceability matrices for medical device components as part of the overall system.
  • Generate comprehensive test reports and ensure proper documentation of results.
  • Risk Management:
  • Participate in risk and hazard analysis, such as Failure Modes and Effects Analysis (FMEA), to identify and mitigate potential risks in the design and manufacturing processes.
  • Perform risk assessments for components and systems, documenting and addressing any non-conformities.
  • Compliance and Documentation:
  • Author and review quality documentation, including Standard Operating Procedures (SOPs), Work Instructions, Validation Plans, Protocols, Reports, Risk Assessments, and Design Control documents.
  • Ensure compliance with FDA, EU, and other international regulatory standards and quality systems.
  • Support audit remediation activities and ensure all records are in alignment with regulatory requirements.
  • Collaboration and Problem Solving:
  • Work with cross-functional teams, including engineering, R&D, and regulatory, to resolve issues related to usability, design, schedule, and resources.
  • Serve as a quality advocate, ensuring adherence to design control processes and promoting quality throughout the product development lifecycle.
  • Continuous Improvement:
  • Identify opportunities for process improvements and implement corrective and preventive actions (CAPA) to enhance product quality and efficiency.
  • Contribute to continuous improvement initiatives related to quality engineering processes and methodologies.
  • Test Environment Management:
  • Set up and manage test environments, prepare test data, and ensure the timely and thorough execution of testing as part of product development and regulatory submissions.
  • Monitor and track project milestones to ensure timely project completion and product release.
Qualifications
  • Education:
  • Bachelor's degree or higher in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related field.
  • Experience:
  • Minimum of 4 years of experience in quality engineering, verification and validation, or related roles in the medical device industry.
  • Strong knowledge of medical device regulations and standards, including ISO 13485, FDA 21 CFR 820, IEC 60601, and ISO 14971.
  • Hands-on experience with risk management techniques such as FMEA, hazard analysis, and design control processes.