Quality Assurance Specialist - Field Actions

iMPact Business Group

  • Portage, MI
  • Contract
  • Full-time
  • 2 days ago
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Quality Assurance Specialist - Field Actions for a 8 month+ Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.Hybrid option after training on Monday and Fri. Data entry experience-documentation- 100+emails a day, attention to detail, organizedKey Responsibilities:
  • Implementing quality standards and ensuring compliance throughout the entire product field action process.
  • Assessing potential risks and recommending actions to mitigate issues while maintaining regulatory compliance.
  • Taking responsibility for all quality control aspects of the process, including intake, record documentation, product destruction, and communication with internal and external customers.
  • Facilitating audits and supporting regulatory inspections by preparing necessary documentation and ensuring process readiness.
  • Coordinating and delivering quality training sessions to ensure understanding and adherence to policies and procedures.
  • Communicating cross-functionally with teams to resolve quality issues and maintain documentation integrity.
  • Monitoring and tracking quality metrics, identifying trends, and driving corrective and preventive actions.
Qualifications:
  • Degree required.
  • Strong understanding of quality assurance principles and regulatory compliance requirements.
  • Excellent attention to detail and organizational skills.
  • Strong communication skills for interacting with internal teams and external stakeholders.
  • Ability to manage multiple priorities and work independently in a fast-paced environment.
  • Experience with quality systems and regulatory requirements in the medical device or healthcare industry is preferred.
  • Familiarity with audit preparation and participation is a plus.
  • Proficiency in quality management software or ERP systems is preferred.

iMPact Business Group