Technician, Quality Control

JenaValve is a privately owned medical device company focused on the design and manufacture of Pericardial Transcatheter Aortic Valve Replacement (TAVR) Systems, intended to treat patients with Symptomatic, Severe Aortic Regurgitation and Stenosis.

Our production site in Leeds, manufactures the proprietary porcine pericardial heart valve used in the JenaValve Pericardial TAVR System.

We are looking to recruit a Quality Control Technician to support the Quality Department with quality control activities related the manufacture of the THV within the Leeds facility.

This role will involve:

• Processing valves utilising Vivtro and BDC vision systems.
• Support maintenance and asset care tasks for the Vivtro and BDC vision systems.
• Support final product release activities.
• Support Quality Control department administration for documents, records, reviewing and completing DHRs.
• Support final valve inspection and testing.
• Complete QC activities associated with the release of labels, product, product packing and incoming raw materials.
• Support the business with internal audit preparation.

• Operating the Vivtro and BDC vision systems.
• Completing asset care tasks to support the Vivtro and BDC vision systems maintenance schedule.
• Quality Control Support Activities, perform inspection and release of WIP labels and labels to be utilised in the final packaging and labelling of finished goods.
• Perform incoming inspection for components and goods against established specifications.
• Support the site in preparation for internal audits and regulatory facility inspections.
• Perform other related duties or tasks as assigned by Quality Control Team Leader or Quality Engineering Manager. 

• High school qualifications from GCSE or A level, or equivalent, is required.
• Minimum of 5 years’ experience working in a manufacturing facility preferably within medical device or pharmaceutical industries.
• Quality Control experience within manufacturing facility would be preferable.
• Experience with electronic document management systems is desired. 

• Must take initiative and be able to complete work under guidance by following detailed manufacturing instructions.
• Must be able to work effectively and collaborate with cross functional teams.
• Must possess the ability to manage multiple tasks, with high attention to detail, associated with product and document processing, and task-based processes relating to a cleanroom environment.
• Good computer skills required with standard MS Office software applications, including Word, Excel, and electronic equipment (e.g., printer/scanner).
• Proficient in spelling, grammar, and communication (verbal and writing) skills.
• Ability to collaborate with cross-functional team members.

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%