TE Connectivity Quality Systems Engineer in Galway, Ireland

TE Connectivity (NYSE: TEL) is a $12 billion global technology leader. Our connectivity and sensor solutions are essential in today’s increasingly connected world. We collaborate with engineers to transform their concepts into creations – redefining what’s possible using intelligent, efficient and high-performing TE products and solutions proven in harsh environments. Our 72,000 people, including over 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS – www.TE.com.

Quality Systems Engineer

The Quality System Engineer is a member of the Quality Systems department. S/he is responsible for ensuring that quality system functions that she s/he is responsible for are maintained in compliance with documented procedures. S/he 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.

Job Responsibilities:

  • 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)

Key Requirements:

  • 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.

Requisition ID: 2017-82139

Business Unit (Current): Industrial Solutions - Medical - Creganna Medical

External Company URL: www.tycoelectronics.com