Job Overview

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.

Job Requirements

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 Quality System requirements

Documentation & Procedures
•    Develop, review, and approve Quality System documentation as required
•    Ensure procedures remain current, effective, and compliant

General Responsibilities
•    Prioritise and manage workload to ensure critical Quality System activities are delivered on time
•    Escalate compliance risks and resource constraints appropriately
•    Support broader Quality or site activities where required, provided core Quality Systems responsibilities are not impacted

What your background should look like

Essential skills and experience
•    Strong working knowledge of ISO13485 and applicable regulatory requirements.
•    Experience in CAPA, internal auditing, customer complaints and audit support, including leading audits and supporting external inspections.
•    Proven ability to lead investigations and drive timely resolution of quality issues, including root cause analysis and follow-up actions.
•    Experience working with electronic Quality Management Systems (eQMS), including data management, tracking and reporting of Quality Systems activities.
•    Experience working cross-functionally and influencing stakeholders across Quality and Operations.
•    Strong problem-solving, organizational and communication skills, with the ability to work independently, manage priorities and escalate risks appropriately.

Physical demands and work environment
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
•    Physical demands: While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arm; balance; stoop; talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
•    Work environment: This role is primarily office-based but may require regular interaction with manufacturing or operational areas. The employee may be exposed to a typical production environment, including noise and moving equipment, and will be required to follow all applicable safety and gowning requirements when entering these areas.

Competencies