Executive / senior industry position
At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.
TE Connectivity is a $13 billion global industrial technology leader creating a safer, sustainable, productive, and connected future. Our broad range of connectivity and sensor solutions, proven in the harshest environments, enable advancements in transportation, industrial applications, medical technology, energy, data communications, and the home. With nearly 80,000 employees, including more than 8,000 engineers, working alongside customers in approximately 150 countries, TE ensures that EVERY CONNECTION COUNTS. Learn more at www.te.comand on LinkedIn, Facebook, WeChat and Twitter.
Creganna Medical is ranked among the top 10 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 companies across 30 countries, Creganna Medical’s customers include the world’s leading medical device and life science 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/
The Quality Engineer is a member of the Operations Quality group. The successful candidate will be responsible for Operations 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 Creganna Medical, part of TE Connectivity products. This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the Creganna Medical, part of TE Connectivity Quality System. The focus of the role is to supply high quality medical devices and components to deliver an Extraordinary Customer Experience.
TE Connectivity's Quality Control and Reliability Teams ensure product and / or product components comply with specifications and quality standards. They test and inspect products against performance and integrity criteria to ensure product quality and reliability, and to determine the suitability of product release.
- The Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
- The Quality Engineer will perform an active role in quality planning and New Product Introduction from a quality perspective.
- Establish and maintain risk management principles and methods throughout the product realisation process in compliance with the company’s Quality Management system and ISO14971.
- Maintain relevant documentation to comply with quality standards and customer requirements.
- Offer quality guidance to a team of Quality Technicians in support of the day-to-day manufacturing operations.
- Develop strong links with customer organisation’s and other project stakeholders.
- 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.
- Establishing inspection standards, sampling plans and test methods.
- Preparing and updating Operations procedures and associated documentation.
- Supporting customer audits and surveillance / accreditation audits.
- Conducting audits of the manufacturing operation and the Quality system ensuring compliance with ISO13485.
- Support Operations area projects and initiatives i.e. Kaizen, data analysis, problem-solving tools, etc.
- Other duties as assigned from time to time.
- Experience within a similar role as a Quality Engineer.
- 3+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
- New product introduction and manufacturing process transfer experience would be a distinct advantage.
- Quality experience in component and device manufacturing desirable.
- Excellent written and oral communication skills essential.
What TE Connectivity offers:
We offer competitive rewards & compensation. Our commitment to our employees includes offering benefit programs that are comprehensive, competitive and will meet the needs of our employees.
- Competitive Salary Package
- Employee Resource Groups