Quality Systems Engineer - 12 month maternity leave

TE Connectivity (NYSE: TEL) is a $12B global technology leader. Our connectivity and sensor solutions are essential in today’s increasingly connected world. We collaborate with customers 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 team members, including more than 7,000 engineers, partner with customers in over 150 countries across a wide range of industries. We believe EVERY CONNECTION COUNTS – www.TE.com

 

Creganna Medical is ranked among the top 3 global companies in the medical device outsourcing industry. The company specializes in the design and manufacture of minimally invasive delivery and access devices for a range of therapies. Serving over 400 customers across 30 countries, Creganna Medical’s customers include the world’s leading medical device companies. Headquartered in Galway, Ireland, Creganna Medical has a global operational footprint with design and manufacturing facilities spanning the U.S., South America, Europe and Asia.  http://www.creganna.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

 

 

Job Overview

TE Connectivity's Quality Assurance Teams are responsible for all or part of an organization's Quality Management System, including conformance and continuous improvement initiatives. They work on systemic evaluation of products, services, facilities, manufacturing or business processes, to ensure that standards of quality are being met. Develop and implement quality plans, programs and procedures using quality control statistics, lean manufacturing concepts, and six-sigma tools and analyses. They reviews, analyze and report on quality discrepancies, investigate problems and executes quality audits, and develops disposition and corrective actions for recurring discrepancies. The team works closely with manufacturing, engineering, customers, or suppliers and subcontractors to ensure requirements are met.

Responsibilities & Qualifications

Competencies

  • Values: Integrity, Accountability,Teamwork, Innovation

Location: 

Galway, G, IE, H91

Alternative Locations: 
Travel:  None
Requisition ID:  43728


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