Quality Assurance Officer

3 days ago

Didcot, United Kingdom The Electrospinning Company Full time

Thanks to our ongoing expansion we’re hiring a Quality Assurance Officer. You’ll support the Quality Manager in ensuring our compliance with medical device quality standards and other applicable regulatory standards and customer requirements.

**The Person**

To thrive in this role, you should have;
- Experience of working in a quality-assurance department preferably in an ISO 9001 and or ISO 13485 certified organisation.
- A working knowledge of Quality Management Systems, Change and Document Control, CAPA and Customer Complaints.
- Self-motivated, resilient, and able to organise own workload and manage competing priorities
- A strong attention to detail and excellent written and verbal communication skills.
- Competent with MS Office software (MS Word, PowerPoint, Excel etc.) and project management software.

Experience with Internal Auditing and software verification and auditing experience would be advantageous, but not essential.

Please note that it's a requirement of the job to be able to work regularly in Personal Protective Equipment (PPE) and, on occasion, with a respirator worn close (seamless) to the face.

**The Role**

You’ll support the Quality Manager on a range of client and inhouse projects, including document control and laboratory compliance checks.

A typical day could include:
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 a 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.

Auditing:

- Support internal audits. A training pathway will be put in place to develop your capability in this area.

**About Us**

**Salary**: £30,000.00-£34,000.00 per year

**Benefits**:

- Company pension
- On-site parking

Schedule:

- Monday to Friday

Ability to commute/relocate:

- Didcot, OX11 0RL: reliably commute or plan to relocate before starting work (required)

Work Location: One location

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