Document Controller | Maldon | 7:30am - 4pm or 8am - 4:30pm | £25,000 - £28,000
The Role - Quality Document Controller
Step into a role where you’ll be at the heart of quality and compliance, managing the flow of critical documentation that keeps production running smoothly.
You’ll take ownership of preparing, verifying, organising and archiving Device History Records (DHRs), ensuring every batch is released accurately and on time. You’ll also oversee the controlled issuance and upkeep of QMS documents, from registration and distribution to archiving and training activation. Your eye for detail and commitment to high standards will help maintain product traceability, support regulatory compliance and keep operations moving efficiently.
Key Responsibilities
- Complete DHR document control activities for priority and production inspection and ensure document control activities are completed within the set target. Ensure verification of DHR documentation is conducted as per approved quality, purchasing and engineering specifications.
- Coordinate and prioritise inspection workload by locating and organising priority parts in accordance with the weekly priority list.
- Undertake and manage production and FAI DHR preparation each week after completion of priority inspection of products.
- Ensure all quality requirements are met during DHR preparation and maintain accuracy by following established QMS procedures. Meet all Quality Control requirements as per corresponding SOPs/WIs.
- Record each product batch in the inspection log using Microsoft Excel. Print the drawing and inspection control plan for each product batch and collate and verify the DHR documentation as necessary.
- Complete weekly batch release for all products. The number of batches to be released each week may vary between 20 to 80. Record batch release activities in the DHR.
- Verify supplier documentation such as Certificates of Conformity (CoC), delivery notes, material certificates, and process certificates are present and correct.
- Verify that batch records completed by previous departments are compliant and complete.
- Take ownership of weekly reprocessing and oversee completion of reprocessing activities as per established procedures.
- Actively liaise with the Design, Supply Chain and Warehouse functions through effective communication and coordinate timely handover of inspected devices.
- Organise the DHR workload to ensure the timely release of priority products.
- Maintain high attention to detail with respect to part numbers, revisions, and LOT numbers to verify product traceability across all records and labels.
- Liaise with suppliers and the QARA function for the timely resolution of documentation queries or deficiencies.
- Verify the label verification of final packed devices and confirm that the DHR record and associated labelling verification tests are correct and compliant with specification. Conduct final verification activities for weekly deliveries from subcontractors.
- Ensure Good Documentation Practice (GDP) is upheld at all times and maintain accuracy of DHR records.
- Scan and archive completed DHR packs at the end of the batch release process and maintain archive and inspection areas in accordance with company policy.
What You’ll Need
- Previous administrative or document control experience within a regulated industry is desirable (e.g. medical, pharmaceuticals, aerospace, or manufacturing).
- Experience handling controlled documentation, records management, or quality system documentation would be advantageous.
- Strong organisational and administrative skills with the ability to manage large volumes of documentation accurately.
- Excellent attention to detail, particularly when reviewing records for completeness, traceability, and compliance with GDP.
- Competent in Microsoft Office applications, particularly Microsoft Excel, Word, and document management systems.
- Ability to follow defined procedures and maintain accurate records in accordance with Quality Management System requirements.
- Good communication skills to liaise effectively with Quality, Inspection, Supply Chain, and Warehouse personnel.
- Ability to manage workload priorities and meet deadlines in a fast-paced manufacturing environment.
The Package
- Salary £25,000 - £28,000 + Annual Bonus 5% of salary, performance related
- Monday to Friday flexible or start/finish times between 7:30am/8:00am 1 hour for lunch 37.5 hour per week
- Annual Bonus 5% of salary, performance related
- Annual leave 21 days holiday plus bank holidays
- Pension scheme 3% employee contribution + 5% company contribution
- Free onsite parking
For more informaiton please contact Sophie Barnes
