Quality & Reliability Engineer (f/m/d)

Job Overview

Reporting to the Quality Manager/Quality Supervisor, the Quality Engineer is a member of the Quality group. The successful candidate will be responsible for Quality within their prescribed area of functional responsibility. They will be working as part of a team to maintain high quality/performance standards on all TE Connectivity products.

This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the TE Connectivity Quality System. The focus of the role is to supply high-quality medical devices and components to deliver an Extraordinary Customer Experience.

Job Requirements

• Working cross functionally with other departments promote the achievement of the health and safety goals


• To deliver on all KPIs that help the business achieve its goal.


• The Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.


• Establish and maintain risk management principles and methods throughout the product realization process in compliance with the company’s Quality Management system and applicable regulations.


• Maintain relevant documentation to comply with quality standards and customer requirements.


• Offer quality guidance to the entire team in support of the day-to-day deliverables.


• Develop strong links with customer organizations and other project stakeholders.


• Support and initiate projects to ensure continuous improvement.


• Quality review of responsible area validation documentation.


• Investigation of root cause and implementation of effective corrective actions to prevent re-occurrence of compliance issues.


• Overall responsibility for production GMP standards and compliance.


• Establish inspection standards, sampling plans and test methods where applicable.


• Prepare and update procedures and associated documentation.


• Support customer audits and surveillance/accreditation audits.


• Conduct and drive audits ensuring compliance with ISO13485.


• The Quality Engineer will perform an active role in quality planning and new product introduction from a quality perspective.


• Develop strong links with customer organizations and other project stakeholders.


• Quality review of responsible area validation documentation.

What your background should look like

Qualifications

• Level 8 degree in Quality or Degree in Science / Engineering / Quality field.


• Minimum of 2 years of industry experience is required.

Key Requirements

• Working knowledge of FDA/ISO/MDD Quality systems for Medical Device companies.


• Experience within a similar role as Quality Engineer is an advantage.


• Quality experience in component and device manufacturing desirable.


• Excellent written and oral communication skills essential.
  
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