Inspector, 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 Inspector to support the Quality Department with quality control activities related the manufacture of the THV within the Leeds and Irvine production facilities.

To include in-process and final inspection, labelling/packaging, documentation, and environmental monitoring. The role holder will also provide routine reports and communications to provide timely updates on inspection status.

• Conduct routine testing on THV, to include functional, visual, and final inspection processes, along with supporting sterilization preparation.
• Perform Microbiological monitoring on ViVitro (Leeds) or BDC (Irvine) when required.
• Conduct Preventative Maintenance and calibration of the ViVitro (Leeds) or BDC (Irvine) equipment.
• Conduct audits on the in-process paperwork associated with the manufacturing process including, but not limited to: manufactured valve DHRs, Jasmine preparation and ancillary logs. Provide support to the Engineering staff by gathering data on clinical product to allow decisions to be made on functionality.
• Adhere to Quality System and record retention requirements.
• Comply with all site Health & Safety requirements.
• Contribute to continuous improvement efforts related to valve manufacture and inspection processes.
• Inspect final packaging labels and confirm they are applied correctly per the relevant standards and Work Instructions.
• Support other areas of the business as necessary and applicable to the role.

• A-Levels, or equivalent and substantial relevant practical experience, in science related subjects are required. Bachelor’s degree in a division of Biology, Chemistry or a Biomedical related discipline is desired (Leeds).
• Minimum of 3-5 years’ experience in Quality within the medical devices or pharmaceutical industries is desirable.
• Must be familiar with 21CFR820 and ISO 13485 requirements. Hands on experience with these requirements is preferred.
• Experience assessing products for compliance and final release is desirable.

• Must be able to work effectively and collaborate within cross-functional teams.
• Must possess the ability to handle multiple tasks, with high attention to detail.
• Ability to file and organize records in a compliant, easily retrievable manner.
• Must be able to effectively articulate (verbally and in writing) results and conclusions.
• Must have good documentation skills.
• Must be able to take initiative and work autonomously with the ability to prioritize a workload.

Salary £29,000 to £31,000 depending on experience.

Benefits:

• Casual dress
• 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%