Quality Coordinator

3 weeks ago

Oxfordshire, United Kingdom MP Jobs Ltd ta MP Recruitment Group Full time

**The Position**

**Please note this is office based**

**Main responsibilities**

**Document Control**:

- Assist the Quality Manager with the maintenance of the ISO 13485 Quality Management System (QMS).
- Create, revise and control documents including standard operating procedures, work instructions, forms, templates and equipment records. This will involve close collaboration with people in manufacturing, R&D, and the facility team.
- Review manufacturing batch records.
- Maintain the internal training database and coordinate quality training activities.
- Initiate, follow up and close concessions, deviations, change control and CAPA (corrective and preventive action).

**Supplier Assurance**:

- Monitor and evaluate supplier performance.
- Perform goods inwards quality inspections of purchased incoming raw materials and consumables.
- Ensure traceability of inventory and products is maintained including physical checks within the warehouse and laboratories.

**Work environment**:

- Support the facility team with remote environmental monitoring system and perform cleanroom particle count measurements to ensure cleanrooms meet requirements of ISO Class 7.
- Perform physical checks on production areas and equipment, including cleaning and maintenance records and calibration status.
- Support internal audits (A training pathway will be put in place to develop your capability in this area)

**Experience and skills**:

- Experience of working in a quality-controlled environment e.g., ISO13485 / 9001 /GLP/GMP.
- Self-motivated, resilient, and able to organise own workload and manage competing priorities
- A strong attention to detail.
- Excellent written and verbal communication skills.
- Competent with MS Office software (MS Word, PowerPoint, Excel etc.) and project management software.
- Software verification and auditing experience would be advantageous.
- Able to communicate openly and highlighting issues promptly and with sensitivity.

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