Manufacturing & Engineering

Quality Specialist - Post Market Surveillance

  • TypePermanent
  • SalaryNegotiable
  • LocationWexford
  • Published2 Mar 2024
  • Ref#BBBH14116
  • Apply now!

Azon Recruitment Group is thrilled to be partnering with an leading global producer of medical devices to recruit for a Quality Specialist in Post Market Surveillance based in their Enniscorthy, Co. Wexford plant!

As a key team member, you’ll take on a vital role in coordinating and managing Post Market Surveillance reports.These key duties extend to analysing, reviewing, trending, and reporting on product safety data to proactively identify potential adverse safety risks or performance trends. Collaborating with cross-functional teams, you’ll ensure compliance with regulations, standards, and company policies across EMEA and the US.

Key Responsibilities:

  • Generate Post Market Surveillance reports, actively participating in planning and reporting.
  • Extract and manipulate data for reports, providing oversight in the analysis of Post Market Surveillance data.
  • Collaborate with Quality, Regulatory, Clinical Affairs, and Operations teams to fulfil data requests and deliver detailed analysis.
  • Identify and escalate instances of non-achieving product performance, evaluating new failure modes.
  • Maintain compliance with global regulations, identifying gaps in Post Market Surveillance processes.
  • Participate in projects aligning with BD Quality, MDD/MDR strategies, and regulatory submissions.
  • Support responses to requests for additional information from competent authorities, registries, and notified bodies.

Requirements:

Essential Skills

  • Bachelor’s degree in Engineering or a similar field.
  • Proficient in Microsoft Office Suite and data manipulation in Excel.
  • Strong interpersonal skills, collaborative mindset, and ability to work independently.
  • Analytic skills with a keen eye for detail and ability to meet tight deadlines. Experience in risk-based decision-making and report coordination.

Advantageous Skills

  • Prior experience in a similar Quality Post Market Surveillance role.
  • Medical device experience, particularly with Class I, II, and III devices.
  • Familiarity with regulations, including ISO 13485, CFR 11820, ISO 14971, and EU MDR.
  • Ability to develop and maintain dashboards using Power BI tools.
  • Experience in technical writing and project management

Emma Griffin

Senior Recruitment Consultant - Manufacturing & Engineering

Emma is a Senior Recruitment Consultant who specialises in Manufacturing and Engineering. After graduating with both a Bachelor of Arts and Master of Arts in History and Italian from the National University of Ireland, Galway, Emma started her career in recruitment in 2021. Her experience recruiting in the Healthcare and Luxury Retail space provided her with an insightful approach to understanding individuals' unique qualities whilst also facilitating more meaningful and successful professional matches within teams and organisations. She collaborates closely with both clients and candidates in Ireland’s most reputable firms to build lasting connections across an ever-growing and exciting field of work.

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