Project Quality Assurance Manager

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 27 days ago

DEKA has an immediate opening for a Project Quality Assurance Manager to work in a fast paced, dynamic Medical Device Research and Development environment. The position reports to the Quality Assurance and Compliance Manager and is a highly visible role with a significant direct impact on the success of projects. The individual works as part of the project team to provide guidance regarding compliance to FDA's Quality System Regulation CFR Part 820, ISO 13485 and company procedures.

Responsibilities include:

  • Ensuring compliance with Quality System Regulations, ISO 13485 and company Quality System and project specific procedures
  • Participation in project Risk Management Process
  • Developing and maintaining project procedures and records for design history file
  • Working within the project team to maintain compliance while helping the project progress through the development process
  • Actively participating in design control planning, design reviews and project meetings
  • Implementing and managing the product development anomaly process including:
  • Developing procedures, providing training to the team, assessing completeness of resolutions, facilitating anomaly meetings
  • Addressing Corrective and Preventive Actions regarding project and systemic issues
  • Develop training material and provide training to the project team
  • Facilitating and managing design transfer activities to manufacturing
  • Reviewing and approving device master records and associated design changes
  • Work with technical person to perform software tool validation and process validation


  • Excellent verbal and written communication skills
  • Five years work experience in a regulated research and development or a manufacturing environment including a clean room, medical device preferred
  • Working knowledge of Part 820 QSR, ISO 13485, Medical Device Directive
  • Working knowledge of computer, office software and general quality tools
  • Experience in Medical device development environment
  • Ability to handle multiple tasks simultaneously and ability to manage project timelines
  • AS or BS in Quality Assurance or an engineering discipline or equivalent experience
  • ASQ certifications; Auditing, Bio-medical auditor, Quality Manager, etc. a plus
  • Experience with Quality System software tools