Senior Quality Systems Engineer

Job Title:

Senior Quality Systems Engineer

At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world.

Job Description:

** Hybrid Role**

The Senior Quality Systems Engineer is a key member of the Quality Systems department. They are accountable for the for the ownership, implementation, performance and continuous improvement of key Quality System Processes at the Medway site. This role ensures that Quality System functions are effectively implemented and maintained in compliance with documented procedures and applicable regulatory requirements (including ISO 13485) and are effectively executed across the site.

The role operates with a high degree of autonomy and is responsible for leading cross-functional activities, driving timely resolution of quality issues, and ensuring audit readiness at all times.

They support and lead the Quality System to ensure ongoing compliance, audit readiness and continuous improvement. This role will liaise with various departments to ensure the Quality System is effectively implemented and remains compliant across the Medway site.
In addition, the role provides flexible administrative and operational support to Quality Operations and the wider site as required, in line with business needs while maintaining accountability for the effective implementation and compliance of assigned Quality System processes.

Role qualifications

• Bachelor’s degree (or equivalent) in Engineering, Science, Quality or a related discipline.
• A minimum of 5 years of related experience with a Bachelor’s degree; or 3 years and a Master’s degree; or a PhD without experience.
• Additional qualification in Quality Assurance or a related discipline is preferred.
• ISO 13485 Auditor training and/or Lead Auditor qualification is preferred.

Quality System Ownership & Compliance

• Own and maintain assigned Quality System processes, ensuring they are fully compliant with internal procedures and applicable regulatory requirements (including ISO 13485)
• Ensure ongoing audit readiness across the site by proactively monitoring system performance and compliance
• Identify gaps or deficiencies in Quality Systems and drive implementation of effective corrective actions

Audit Management

• Lead and manage internal and external audits, including planning, execution, stakeholder coordination, and closure of audit findings
• Ensure timely and effective response to audit findings, including ownership of corrective actions and verification of effectiveness, where applicable
• Act as primary site-based contact for Quality Systems-related audits and inspections

CAPA & Investigations

• Own and drive CAPA activities, including investigation, root cause analysis, implementation of corrective and preventive actions, and effectiveness verification
• Ensure CAPA activities are completed in a timely and compliant manner
• Escalate risks, delays, or systemic issues to management as appropriate

Customer Complaints & RMA Processes

• Own and oversee the Customer Complaint and RMA processes at site level, ensuring effective execution, compliance, and timely closure
• Ensure appropriate investigation, documentation, trending, and communication related to complaints
• Monitor process performance and drive improvements where required

Change Control & Training

• Ensure effective implementation and compliance of change control processes, providing direction and oversight to change owners
• Own or oversee Quality Systems-related training processes to ensure requirements are defined, training is completed, and effectiveness is maintained

Data, Metrics & Management Review

• Develop, analyse, and communicate Quality Systems metrics to stakeholders
• Interpret data trends, identify risks, and drive improvement actions
• Lead preparation and maintenance of Management Review inputs related to Quality Systems

Continuous Improvement & Leadership

• Lead Quality Systems improvement initiatives aligned with site and global Quality objectives
• Act as subject matter expert for Quality Systems, providing guidance and direction to cross-functional teams
• Influence stakeholders to ensure adherence to…