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.
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)
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