Engineer, Quality Systems

JenaValve is a global medical device company focused on developing and manufacturing innovative Transcatheter Aortic Valve Replacement (TAVR) systems for the treatment of patients with severe aortic regurgitation and aortic stenosis.

Our mission is to raise awareness of aortic regurgitation and transform treatment options for patients living with this condition.

Our Leeds manufacturing facility produces the proprietary porcine pericardial tissue valves used within the JenaValve TAVR System.

Joining JenaValve means becoming part of a team that is dedicated to delivering high-quality medical devices and supporting advancements in patient care across the world.

JenaValve is seeking an experienced and motivated Quality Systems Engineer to support the development, implementation, measurement and continual improvement of our Quality Management System (QMS) while providing direct quality engineering support to manufacturing operations.

This role plays a key part in ensuring compliance with regulatory requirements, maintaining the highest standards of product quality and patient safety, and supporting the manufacture of Class III implantable medical devices.

Working closely with production, engineering and quality teams, the successful candidate will drive quality performance, investigate quality issues, support continuous improvement initiatives and promote a strong quality culture across the business through training, coaching and stakeholder engagement.

The position combines quality systems management with hands-on support to manufacturing operations, ensuring products are manufactured in compliance with ISO 13485, 21 CFR 820 and other applicable regulatory standards.

• Own and monitor Quality Management System performance metrics and key performance indicators.
• Analyse quality system data to identify trends, risks and opportunities for improvement.
• Prepare and deliver quality reports for leadership review and management review processes.
• Manage non-conformance systems and determine appropriate escalation to CAPA, Health Hazard Evaluation (HHE) or Field Safety Corrective Action (FSCA) processes.
• Lead quality improvement projects arising from underperforming quality system processes.
• Maintain quality system documentation, ensuring records are accurate, controlled and readily accessible.
• Conduct internal audits and support supplier and third-party audits, ensuring findings are appropriately managed and closed.
• Develop and deliver training on quality system processes, procedures and regulatory requirements.
• Support additional quality initiatives and projects as required.

• Act as the primary quality point of contact for manufacturing operations, providing real-time quality guidance.
• Review, investigate and disposition non-conforming materials in accordance with company procedures and risk management principles.
• Participate in Material Review Board (MRB) activities and support effective resolution of quality issues.
• Support incoming, in-process and final inspection activities to ensure compliance with product and regulatory requirements.
• Review production deviations, temporary changes and change requests, assessing potential impact on product quality and patient safety.
• Support root cause investigations and corrective and preventive action activities.
• Prepare, review and maintain production-related quality documentation, procedures and work instructions.
• Deliver quality and compliance training to manufacturing teams.
• Support validation activities relating to production processes, equipment and software.
• Escalate production quality risks, trends and concerns to leadership as appropriate

• Bachelor's degree in a relevant discipline, or equivalent combination of quality certifications and experience.
• Minimum of 3-5 years' experience within quality systems, quality assurance or quality engineering in a medical device or highly regulated environment.
• Knowledge of applicable regulations and standards including ISO 13485, EU MDR and 21 CFR 820.
• Lead Auditor certification is highly desirable.
• Supplier auditing experience is highly desirable.
• Understanding of risk management principles and their application within highly regulated medical device environments.
• Experience supporting manufacturing operations, non-conformance management, root cause investigations and product release activities is advantageous

• High level of personal integrity, professionalism and accountability.
• Strong attention to detail with a focus on compliance and quality.
• Excellent analytical, problem-solving and decision-making skills.
• Ability to work independently and manage multiple priorities effectively.
• Strong project management and stakeholder engagement capabilities.
• Effective communication and training delivery skills.
• Comfortable working within manufacturing and cleanroom environments.
• Ability to make sound, risk-based decisions in support of product quality and patient safety.
• Collaborative approach with the ability to influence and work effectively across departments

Salary:

From £45,000 per year depending on experience

Benefits:

• Company pension
• Free parking
• Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus