02 September 2020

QA Engineer

Posted in Open Positions, United States

Job Title:  QA Engineer
Department:  QARA
Location: COSMED USA, Concord

The qualified applicant will perform activities to ensure that the company’s quality system is in compliance with requirements of various governmental and regulatory agencies and also assist in preparing regulatory submissions if and when required.

Key Responsibilities

  • Quality System
  • Maintain and continue to improve the company’s quality system
  • Provide Quality System training to existing and new employees
  • Manage and document corrective/preventive action and non-conformance processes
  • Report to top management on all quality and regulatory related issues
  • Perform internal audits, calibration and document Control activities
  • Act as the liaison with external agencies/organizations on quality matters
  • If applicable, based on skills, take on additional responsibilities
  • Regulatory Affairs                               
  • Prepare domestic and international submissions to obtain quality and regulatory approvals from regulatory bodies and certification agencies
  • Act as the liaison with external parties on regulatory matters
  • Keep abreast of regulatory landscape and proactively address changes to existing or new laws
  • Engineering
  • Act as the liaison with external parties for EN 60601-1 product safety testing
  • Assist Engineering Team with small projects and documentation

 

Requirements

  • Master degree in Drug/Medical Regulatory Affairs
  • Minimum of 6-months of industry experience
  • Strong knowledge of FDA Quality System Regulations:
  • Reports to Director of Operations

 

QA Engineer Skills

  • Good interpersonal and group communication skills
  • Ability to work within a cross-functional team
  • Attention to detail and ability to multi-task
  • Strong writing skills

 

COSMED is a leader in providing Cardio Pulmonary Diagnostics systems and software. COSMED systems are used in Universities, Hospital, Physiology research, gait analysis, CP rehabilitation. Our customers range from high end research institutes, universities, hospitals to Doctors/GPs and companies involved in Health & Wellness Industry.

If interested, please send your CV with an introduction letter to This email address is being protected from spambots. You need JavaScript enabled to view it. 

NOTE: The above statements are intended to describe the general nature and level of work. Additional duties might be assigned. Management retains the right to add or change duties of the position at any time.