2 x Quality Systems Engineers(1 permanent & 1 x 12 Month Contract) is required by CareerWise Recruitment for our Galway based client. The Quality System Engineer is a member of the Quality Systems department. They are responsible for ensuring that quality system functionsr are maintained in compliance with documented procedures. Supports the Quality System to ensure on-going compliance and continuous improvement. This function will liaise with various departments to ensure the quality system is in compliance. Please contact Tom Devaney for more information.
Role of this position
- Actively stays current with external and internal quality system standards and requirements.
- Providing Quality Systems support for the Galway site.
- Support QMS integration activity across the Galway site.
- Responsible for coordinating and managing all external audits.
- Responsible for managing the site internal audit process.
- Responsible for managing the site internal CAPA process.
- Approvals as defined on Oracle.
- Identifies deficiencies in quality systems and defines systematic corrective actions.
- Develops effective quality metrics and communicates the results to key stakeholders using reports, presentations, and dashboards.
- Ensure compliance and drive improvements in QS processes.
- Assists in the preparation and maintenance of records associated with the management review process.
- Participates in Quality Systems projects under the direction of the Quality Director as well as other duties as assigned.
- Monthly Manufacturing Training Report (provided to HR, accounting for all training data analysis)
- Level 8 Degree in Quality Assurance or Degree in Science/Engineering with an additional qualification/experience in Quality Assurance.
- A minimum of 2 years experience as a Quality Engineer within the Medical Devices or Pharmaceutical industry.
- Strong working knowledge and proven track record in the all aspects of ISO13485 and FDA QSR requirements.
- Regulatory experience / knowledge.
- Excellent communication and inter-personal skills.
- Proven ability to influence.
- Excellent attention to detail and report writing skills.
- Highly organized with strong ability to prioritize tasks and work on own initiative.
- Trained Auditor ideally lead auditor training and/or experience
Please call Tom Devaney today for further information on 091-758771 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)