Quality Assurance Specialist
Medical Devices / ISO13485 Quality Management Systems - Essential
Location: Heywood
Salary: £40K+
The Role
Our client is seeking a Quality Assurance Specialist to support and continually improve their Quality Management System within a regulated Medical Device manufacturing environment.
Role focuses on:
- Continued regulatory compliance to ISO13485, whilst assisting with Technical Documentation under (EU)2017/745, (EU)2017/746 to maintain device compliance.
- Maintain and improve the company's Electronic Documentation Management System (EDMS) by Progressing, reviewing and update quality procedures, risk assessments and work instructions.
- Key contact for quality/compliance whilst hosting external regulatory and accreditation bodies.
- Coordinate and manage the internal/process audit programme to drive improvement assisted alongside external consultancy.
- Manage document control processes and quality documentation through the EDMS.
- Monitor/Investigate customer complaints and non-conformities along with CAPA/root cause activities.
- Track audit findings and Identify gaps within existing quality systems and implement improvements ensuring agreed actions are completed in timely manner by stakeholders.
- Enhance compliance with ISO13485, ISO9001 and Medical Device requirements using initiative.
- Approving product literature and artwork to ensure they meet regulatory requirements
The successful candidate will work closely with senior management, whilst corroborating with external consultancy team to drive compliance for the company.
Essential
Previous experience in Quality Assurance or managing a QMS within a regulated environment.
Experience managing CAPAs, complaints and non-conformances
Strong documentation and procedural writing skills
Desirable
Experience with internal auditing
ISO13485 experience within MD environment.
PLEASE NOTE
To be considered for this position, you must have:
✔ Previous Quality Assurance experience preferably within a Medical Device environment
AND/OR
✔ Experience working with ISO13485 Quality Management Systems.
This is a documentation, compliance and quality systems role with some external travel and some hybrid working will be considered after probationary period. Laboratory, inspection, testing experience will only be considered where significant involvement within Quality System/documentation can be demonstrated.
Please note that only shortlisted applicants will be contacted
Pay: From £40,000.00 per year
Benefits:
- Company pension
- Free parking
- Health & wellbeing programme
- Life insurance
- On-site parking
- Private medical insurance
Experience:
- managing CAPAs, complaints and non-conformances: 3 years (required)
- strong documentation and procedural writing: 3 years (required)
- Quality Assurance or managing QMS: 3 years (required)
- QA within Medical Devices and/or ISO13485: 3 years (required)
- QA or managing QMS within a regulated environment: 3 years (required)
Work Location: In person
