Senior Specialist QA

3 weeks ago

Cork, Cork, Ireland TN Ireland Full time
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Develops and applies sound knowledge and understanding of the QA frameworks, legislative requirements, processes, and procedures in the EMEA distribution organization. Responsible for developing and maintaining the QMS and ensuring compliance with the ISO 9001 standard.

Key Activities & Accountabilities
  • Along with the QA Manager and QA team, responsible for ensuring compliance with the ISO 9001 standard across UK&BNN sites.
  • Develop and maintain UK&BNN QMS and documentation system to ensure sites operate within approved Corporate and Regional EMEA processes and procedures.
  • Ensure quality records are established and maintained to provide evidence that the QMS is being followed, with systems in place for identification, storage, protection, retrieval, retention, and disposition of such records.
  • Support annual Management Reviews of the Quality System to ensure and monitor its suitability, adequacy, and effectiveness.
  • Support a program of Internal Quality Audits covering all processes.
  • Support continual improvements of the QMS, ensuring that evidence of corrective and preventive actions taken are recorded and reviewed. Collaborate with process owners for timely CAPA investigations and closures.
  • Assist in creating a QMS training program. Ensure all new staff are inducted into the QMS requirements related to their roles and responsibilities, and provide updates as necessary.
  • Analyze data on QMS effectiveness and evaluate opportunities for continual improvement, including data from monitoring, measurement, and other relevant sources.
  • Support departmental process owners in identifying, implementing, and documenting improvement opportunities.
  • Assist in creating quality objectives for RAQA and non-RAQA departments.
  • Report to management on QMS performance and areas needing improvement.
Education

BSc degree in a relevant field. An advanced degree is preferred.

Experience

2-4 years of relevant experience.

  • Project support, time management skills, writing, coordination, and execution of complex QA tasks.
  • Demonstrated knowledge and application of quality requirements, including ISO 9001.
  • Knowledge of environmental quality standard ISO 14001 is an advantage.
  • Some technical knowledge of medical device quality requirements.
  • Ability to develop influence across the organization.
  • Coordinate and support technical and scientific QA activities.
  • Ability to work under minimal supervision and make decisions within relevant areas of competence.
  • Clearly communicate information to peers, supervisors, and stakeholders across the EMEA organization, Design Divisions, and third-party distributors.
  • Attend meetings with regulatory agencies, internal and external audits, and other stakeholders.
  • Prepare briefings and informational documents.
  • Seek out diverse ideas, opinions, and insights, applying them in the workplace.
  • Connect and relate well with people who think and act differently.
  • Embrace scrutiny and feedback as opportunities to learn and improve.
  • Prepare QA metrics for reporting purposes.
  • Maintain high attention to detail and process consciousness.
  • Fluent in English and the local language where applicable.
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