Job Purpose

The Quality Assurance Specialist is responsible for supporting the Quality Management System throughout the organization in support of product maintenance, development, and growth.  The Quality Assurance Specialist will, with direction, be responsible for document management, QMS training, complaint and CAPA management.

Duties and responsibilities

As the Quality Assurance Specialist, this position will:

  • Own and lead the document management process within DeepHealth, including configuration management.
  • Work cross-functionally to lead the complaint management process, including investigations, customer interactions, and reporting to management
  • Lead the CAPA management process to work cross functionally to identify root causes, and implement remediations
  • Lead the QMS training (and retraining) for DeepHealth to ensure compliance with US and International requirements.
  • Assist in the evaluation and qualification of suppliers.
  • Complete Quality System Audits (internal and external audits) to ensure compliance.

Please Note: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above.  Other functions may be assigned, and management retains the right to add or change duties at any time.

Qualifications

Qualifications include:

  • Bachelor’s degree in relevant field (or equivalent experience, i.e. Associates Degree with 3 years of experience).
  • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820.
  • Knowledge of EU Medical Device Regulation (MDR), ISO13485, ISO 14971, and IEC 62034 preferred.
  • 2 – 4 years working in a regulated industry (FDA and Software as a Medical Device preferred).
  • Participation in regulatory audits a plus.
  • Excellent written and oral communication skills.

Physical Requirements

This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.

Contact Us About This Position

We’re always looking for talented, motivated individuals to join our team – get in touch!