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.
