Senior Quality Systems Engineer

About the role

The Senior Quality Systems Engineer is a key member of the Quality Systems department. They are accountable 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.

Responsibilities

• 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
• 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
• 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
• Own or oversee Quality Systems-related training processes to ensure requirements are defined, training is completed, and effectiveness is maintained
• 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
• 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
• Develop, review, and approve Quality System documentation as required
• Ensure procedures remain current, effective, and compliant
• 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

Requirements

• 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

Qualifications

• 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

Benefits

Comprehensive benefits package including health insurance, 401(k), disability, life insurance, employee stock purchase plan, paid time off and voluntary benefits.

Pay

Competitive base salary commensurate with experience: $92,900-116,100 (subject to change dependent on physical location)

Schedule

Not specified