TE Connectivity is Looking for QLTY & RELIABILITY ENGINEER II Full Time

The Quality Engineer – NPD in the metals component are of NPD will provide Quality support to our New Product Development team in ensuring the metals component manufacturing processes are developed to meet customer requirements, and the regulatory requirements of medical devices manufacturing.

The quality engineer will form part of a cross-functional team and including process development engineers with varying expertise in areas relating to medical devices metals processing.

The quality engineer will be the expertise within the team in ensuring that the project team are: (i) developing a product in accordance with expected manufacturing quality standards;

(ii) considerate of regulatory aspects important for a medical devices manufacturing process, including areas such as process validation, process optimization/improvement, failure investigation, and

(iii) ensuring that development project can be scaled and transferred to a commercial manufacturing setting.

• Participate in the New Product Development business as the quality voice in the development team – ensuring that quality is built into all component products through all stages of the product life cycle
• Ensure product development process and project team achieve and maintain compliance to the Quality Management system in all aspects of the New Product Development process.
• Ensure that process development projects are delivered to comply with required industry process validation principles.
• Familiar with procedure and documentation generation and applying Lean principles to establishing process instructions.
• Establishing inspection standards, plans, sampling frequencies and test methods, and familiar with practical application of quality engineering tools.
• Performing reviews of established production and system procedures to identify efficiency enhancements and prevention of errors.
• Identifying and implementing effective production and process controls to maintain product quality and manufacturing effectiveness.
• Work with suppliers and customers on the resolution of product quality issues and identify quality improvement programs to sustain supplied material quality.
• Proficient in the use of quality engineering tools and ideally applying statistical software to support process investigations and identifying improvements.
• Drive continuous improvement and innovation within the project team.

• Level 8 Engineering or Science Degree.
• 3+ years’ experience in a similar role.
• Previous medical devices manufacturing development and/or manufacturing experience in an ISO13485 certified QMS environment is an advantage.
• Ability to apply a structured problem-solving approach and Six Sigma tools and methodology familiar is an advantage.
• Proficient in technical communication with excellent attention to detail is necessary.
• Experience in dealing with customers, as quality lead on projects, is an advantage.

Values: Integrity, Accountability, Teamwork, Innovation