Senior Specialist, Document 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 Senior Specialist Document Control to support and lead document control, review and revision including archiving and retrival.

The role would also support the QA/RA department in coordinating, organising, documenting and maintaining quality systems records.

• Process document/item change orders by ensuring they are according to and compliant with document control procedures.
• Ensure all records received are filed in compliance with QSRs and ISO standards.
• Ensure retention requirements are met for all Quality records.
• Maintain training matrix log and file associated training records.
• Assign document numbers upon request.
• Support QA in preparation of an internal and external audits/regulatory facility inspections.
• Research and retrieve documents as requested.
• Train and supervise junior members of department.

• Complete product release tasks including but not limited to, release of WIP labels, and labels to be utilised in the final packaging and labelling of finished goods.
• Review manufacturing and product handling records associated with tissue and valves and review these for completeness, accuracy, and GDP compliance. Work directly with the data originators to have errors corrected prior to record approval and product release.

• Educated to degree level, a BA in Business Administration is desired.
• A minimum of 7 years’ experience in Quality within the medical devices or pharmaceutical industries is required.
• Must be familiar with 21CFR820 and ISO 13485 requirements. Hands on experiences with these requirements is preferred.

• Able to work effectively and collaborate within cross functional teams.
• Able to handle multiple tasks with high attention to detail associated with document handling, archiving, and change control.
• Able to read / understand design and manufacturing drawings and documents.
• Familiar with bills of materials.
• Able to file and organize records.
• Knowledge of document scanning and printing equipment; must be able to utilize electronic files.
• Able to effectively articulate (verbally and in writing) results and conclusions.
• Must have good documentation skills.
• Must take initiative and be able to conduct hands-on work.

Salary:

From £40,000 per year depending on 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