Technician, Quality Control

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 a motivated and detail-oriented Quality Control Technician to support a range of quality control activities critical to the manufacture and release of our Class III medical devices. This role plays an important part in ensuring products, materials and documentation meet the highest standards of quality, compliance and traceability.

Working within the Quality Control team, you will support final product inspection and release activities, operate specialised vision systems used for valve processing and inspection, perform incoming goods inspections and support quality records management. This is an excellent opportunity for an individual with manufacturing or quality experience who enjoys working in a highly regulated environment where attention to detail is essential.

• Operate the Vivtro and BDC vision systems used for valve processing and inspection activities.
• Support final valve inspection and testing activities.
• Complete Quality Control activities associated with the release of products, labels and packaging components.
• Support final product release processes in accordance with approved procedures.
• Assist with Quality Control department administration, records management and documentation activities.



• Perform incoming inspection of components and materials against approved specifications.
• Inspect and release work-in-progress labels and labels used in final product packaging.
• Review and complete Device History Records (DHRs) and associated quality documentation.
• Ensure inspection and release activities are completed accurately and in compliance with quality requirements.
• Maintain accurate records of inspections and product release activities.

• Complete asset care activities to support the maintenance schedule for Vivtro and BDC vision systems.
• Support preparation activities for internal audits and regulatory inspections.
• Ensure compliance with Quality Management System requirements, procedures and documentation controls.
• Assist with departmental projects and continuous improvement activities as required.
• Support additional quality-related tasks assigned by the Team Leader, Quality Control or Quality Engineering Manager.

• GCSEs, A Levels or equivalent qualifications are required.
• Minimum of 5 years' experience working within a manufacturing environment, preferably within the medical device or pharmaceutical industry.
• Previous Quality Control experience within a manufacturing setting would be advantageous.
• Experience working with electronic document management systems is desirable.
• Familiarity with quality-controlled environments and manufacturing documentation processes is beneficial.

• Strong attention to detail and ability to follow detailed manufacturing instructions.
• Ability to work independently while maintaining a high level of accuracy.
• Strong organisational skills with the ability to manage multiple tasks and priorities.
• Good computer skills, including Microsoft Word, Excel and electronic office equipment.
• Effective written and verbal communication skills.
• Ability to work collaboratively with cross-functional teams.
• A proactive and flexible approach to supporting business and departmental priorities.
• Commitment to quality, compliance and continuous improvement.
• Ability to work within a cleanroom and regulated manufacturing environment.

• Work within a controlled manufacturing and cleanroom environment.
• Follow strict quality, contamination control and safety requirements.
• Wear appropriate cleanroom gowning and personal protective equipment (PPE) as required.
• Support the manufacture and release of Class III medical devices within a highly regulated environment.

Salary: £27,143.00 per year

Benefits:

• Company pension
• Free parking
• AXA Private medical insurance
• Employee Referral program
• Company sick pay
• 28 days holiday plus public holidays
• Discretionary corporate bonus: up to 5%