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Quality Systems Analyst

  • Job reference: 925765
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 30/05/2019

Orion Group are currently recruiting for a Quality Systems Analyst on behalf of our Multinational Medical Device Client on an initial 12 month contract which is based in Cork.

Position Title(s) :
Quality Systems Analyst

1. Job Purpose:
Short statement stating exact purpose of the role:
This position will support the execution of the Site's Quality Management System Processes and participate in Quality System projects. This person will drive the flawless and compliant execution of the assigned processes to meet customer and business needs while ensuring the processes are in compliance with regulatory requirements.
2. Responsibilities:
List main areas of responsibility:

− 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. Utilizes quality tools to track, trend and communicate quality performance metrics in presentations/reports/dashboards.
− 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
− All employees are responsible for minimizing both the environmental and Health and Safety effects of the work they perform.

3. Education and Experience Required for Role
Essential:
− Third level qualification (Science or an Engineering related discipline)
− Planning and organizing skills
− Excellent PC, interpersonal and influencing skills


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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