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Quality Systems Analyst

Ref: 75675

  • 35,000-40,000
  • 09 Sep 2021
  • Cork (Centre)
  • Permanent

Quality Systems Analyst

About the Company

A Quality Systems Analyst is required by a leading Medical Device manufacturer in Cork. In this role you will support the flawless execution of the Site Quality System.

About the Position

Key Responsibilities 

Drives compliant execution of the following for their
assigned processes and projects:
  • Manages specified quality system processes.
  • Works directly with various customers of the quality system processes to ensure compliance to site, sector/franchise/regulatory requirements.
  • Work directly with the various owners/teams to ensure investigations/actions are implemented and accurately documented in a timely manner
  • Compiles contextualizes, evaluates and presents Quality Systems data and metrics for all metric review meetings. 
  • Understand and uses data, key metrics and statistical methods, quality tools or computer-based solutions to improve processes
  • Responsible for identifying and communicating the need for process improvement opportunities to responsible management.
  • Proactively examines/reviews systems and processes, to identify/assess areas for review, improvement, change, or elimination and with specific focus in simplifying and standardizing processes. Lead and drive improvements as required
  • Support the assigned processes during internal and external audits.
  • Where applicable, conducts internal audits to ensure compliance to regulatory and customer requirements. Responds to and drive/ participates in investigations and corrective action implementation for identified quality issues including internal/external audits actions
  • Assists in creating a culture of quality awareness and communicating the quality management system, GMP and associated documents and procedures to all staff

Experience/Requirements 

  • BS Degree in Business, Engineering, or related field.
  • 2+ years of experience in Medical Device or Pharma Quality systems
  • Advanced degree highly desirable as well as knowledge of FDA Regulations.
  • Planning and organizing skills
  • Excellent PC, interpersonal and influencing skills
  • Proficiency in applicable GMP/QSR regulations and in- depth knowledge of Quality Systems

Remuneration Package

€35,000 - €40,000
Contact

For more information on the role or any other Engineering or Life Sciences roles call Nigel on 087 3618142 or email me or click the apply button below.