Senior Quality Engineer

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.

We are seeking an experienced and motivated Senior Quality Engineer to provide quality engineering support across product development, manufacturing and quality system activities within a highly regulated medical device environment.

This role plays a key part in ensuring products, processes and systems comply with regulatory requirements while supporting continuous improvement, risk management and operational excellence.

Working closely with Quality, Manufacturing, Engineering and Regulatory teams, the successful candidate will lead validation activities, quality investigations, process improvement initiatives and risk management activities while helping to maintain the highest standards of product quality and patient safety.

• Provide quality engineering support across manufacturing, design verification and validation activities.
• Partner with Manufacturing Engineers to develop, qualify and optimise manufacturing processes.
• Review and approve design changes to ensure compliance with applicable quality and regulatory requirements.
• Provide technical quality support for new processes, procedures and standards.
• Support the review and interpretation of industry standards and regulatory requirements.

• Develop, execute and approve protocols and reports for equipment qualification activities (IQ/OQ/PQ).
• Support design verification, validation and continuous improvement projects.
• Lead and support Gage R&R studies and process validation activities.
• Assist in the development and implementation of the Validation Master Plan.
• Drive cross-functional improvement projects to enhance product quality, compliance and operational performance.

• Review production records and quality documentation to ensure products are manufactured in compliance with Quality System Regulations and ISO standards.
• Review, approve and maintain manufacturing documentation and records.
• Conduct manufacturing audits to assess compliance with approved procedures.
• Execute internal and supplier audits and support closure of audit findings.
• Support quality system processes including Supplier Quality, CAPA and post-market surveillance activities.
• Maintain equipment calibration and preventative maintenance activities in accordance with approved procedures.

• Lead cross-functional teams in the development of risk management documentation, including Process FMEAs and related risk assessments.
• Lead root cause investigations into production-related non-conformances and quality issues.
• Develop and support implementation of corrective and preventive actions.
• Support risk-based decision making to ensure product quality and patient safety.
• Mentor and support junior Quality Engineers in quality engineering principles and activities.

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum of 4 years' Quality, Regulatory or Quality Engineering experience within the medical device, pharmaceutical or life sciences sector.
• Experience managing non-conformances, investigations, root cause analysis and corrective and preventive action activities.
• Strong understanding of risk management principles and methodologies.
• Working knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 requirements.
• Experience supporting validation, manufacturing and continuous improvement activities within a regulated environment.

• Strong project management and organisational skills.
• Excellent analytical and problem-solving capabilities.
• Ability to manage multiple priorities while maintaining attention to detail.
• Effective verbal and written communication skills with the ability to present information to both technical and non-technical audiences.
• Ability to work collaboratively within cross-functional teams.
• Demonstrated initiative with a hands-on approach to problem solving.
• Ability to identify priorities and deploy resources effectively to meet business objectives.
• Strong technical documentation and report writing skills.
• Commitment to quality, compliance and continuous improvement.

• Work within a highly regulated medical device manufacturing environment.
• Collaborate closely with Quality, Manufacturing, Engineering and Regulatory teams.
• Support activities within laboratory, manufacturing and cleanroom environments as required.
• Maintain compliance with all quality, safety and contamination control requirements.

Salary: Subject to Experience

Benefits:

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