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Quality Systems Associate

Job description

Quality Systems Associate

Work within a global and growing diagnostics company who are changing lives globally with fast acting technology stopping highly infectious diseases from impacting communities globally. This company have expanded greatly over the past decade through acquisitions, breaking into new markets and developing new cutting-edge technology providing faster results for patients and health professionals. This role will support the Post-Market Surveillance team to manage global complaint management.

Responsibilities:

  • Assist in the establishment and development of global complaint management and quality reports.
  • Support recurring complaint intake and entry into the QMS, assisting with strategy development in stakeholder team meetings.
  • Support site audits, ensuring relevant regulatory standards and global internal standards are met and implemented.
  • Utilise data analysis techniques regarding ongoing issues with customers.
  • Demonstrate good understanding and the ability to adhere and implement ISO, FDA, and other regulatory standards.
  • Assist in managing and developing internal and Global QMS.
  • Act as a cross functional team member representing the Global Post Market Surveillance team.

Requirements:

  • Bachelor’s degree in Science or Engineering with a prior knowledge of US and global regulations related to medical device complaint handling and regulatory reporting in accordance with 21 CFR Part 820.198, 21 CFR Part 803, ISO 13485, MEDDEV 2.12-1 and others.
  • Prior Medical Device, Biotechnology or similar STEM related industry experience.

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

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