QLTY & RELIABILITY ENGINEER II

Job Overview

Ensures that products being built and processes being used adhere to all standards and requirements; implements quality assurance practices, processes, and procedures. 

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

• Bachelor's degree in Quality or Degree in Science / Engineering / Quality field.

• Minimum of 3 years of progressively responsible professional level 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.

Competencies