QUALITY & 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 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 Medical Quality System. The focus of the role is to supply high quality components to deliver an Extraordinary Customer Experience.

Key Job Responsibilities:

• Collaborate with engineering, production, and planning teams to continuously improve product quality throughout the manufacturing process.
• Chair the Material Review Board meetings to facilitate the closure of nonconforming records and identify trending issues within manufacturing using statistical methods.
• Identify and perform the necessary containment activities for nonconforming material identified in-process and at final inspection.
• Collaborate with a cross functional group to investigate nonconforming products using root cause analysis tools (i.e. Ishikowa, 5-Whys, Is-Is not, etc.) to identify the corrective actions necessary to prevent the recurrence of the issue.
• Communicate with customers regarding product related complaints to facilitate the evaluation and return of the material to TE Connectivity.
• Investigate product quality issues related to customer returns (e.g., non-conforming material reports & corrective action).
• Create and update operations procedures and associated documentation used within production.
• Help ensure compliance to quality assurance policies and procedures to meet or exceed customer expectations.
• Implement continuous improvement initiatives to reduce defects, improve efficiency, and enhance overall product quality.
• Conducting audits of the manufacturing operation and the Quality system ensuring compliance with ISO13485. 

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 preferred.
• 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