QLTY & RELIABILITY ENGINEER II

Job Overview

Reporting to the Quality Manager, the Operations Quality Engineer is a member of the Operations Quality group.
S/he is, responsible for Operations Quality within their prescribed area of functional responsibility.
S/he will be working as part of a team to maintain high quality / performance standards on all TE Medical products.
This challenging position will require an ability to work within a collaborative environment, pursuing continuous improvement and ensuring compliance to the TE Medical Quality System. The focus of the role is to supply high quality medical devices and components to deliver an Extraordinary Customer Experience.

Key Job Responsibilities:

• Working with the Supervisor and manufacturing engineering 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 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 organizations 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.
   

What your background should look like:

• Degree in Quality or Degree in Science / Engineering.
• Experience within a similar role as quality engineer.
• 3+yrs industry experience in a medical device-manufacturing or pharmaceutical environment.
• Working knowledge of FDA/ISO/MDD Quality systems for medical device companies.
• Quality experience in component and device manufacturing desirable.
• Excellent written and oral communication skills essential.

Competencies