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Quality Assurance Specialist

ELS Recruitment Ltd
Heywood

Quick apply

Job details

Permanent | Full-time
£40,000 - £56,000 a year

Benefits

Free parking
Company pension
Private medical insurance
On-site parking

Qualifications

GCSE
Quality management
ISO 9001
Analysis skills
Quality assurance
Bachelor's degree
Quality control
Internal audits

Full job description

Quality Assurance Specialist

Medical Devices / ISO13485 Quality Management Systems - Essential

Location: Heywood

Salary: depending on experience

PLEASE NOTE

To be considered for this position, you must have:

✔ Previous Quality Assurance experience within a Medical Device environment

✔ Significant experience working with ISO13485 Quality Management Systems

This is a documentation, compliance and quality systems role. It is not a laboratory, inspection, testing or hands-on Quality Control position.

Applicants without Medical Device and/or ISO13485 experience are unlikely to be considered.

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.

This is a predominantly office-based role focused on:

Quality Management Systems (QMS)
ISO13485 compliance
Internal auditing
CAPA management
Complaint investigations
Documentation control
Regulatory compliance
Process improvement

The successful candidate will work closely with senior management and regulatory bodies to ensure ongoing compliance and quality excellence.

Key ResponsibilitiesQuality Management Systems

Maintain and improve the company's Quality Management System (QMS)
Develop, review and update quality procedures, policies and work instructions
Identify gaps within existing quality systems and implement improvements
Manage document control processes and quality documentation
Support the maintenance of the electronic Quality Management System

Auditing & Compliance

Coordinate and manage the internal audit programme
Support external audits by regulatory and accreditation bodies
Track audit findings and ensure agreed actions are completed
Monitor compliance with ISO13485, ISO9001 and Medical Device regulatory requirements

CAPA, Complaints & Non-Conformances

Investigate customer complaints and non-conformities
Coordinate CAPA activities through to closure
Monitor complaint and non-conformance trends
Support root cause investigations and corrective actions

Regulatory Support

Act as a key contact for quality and compliance matters
Support communications with MHRA and Notified Bodies
Assist with regulatory compliance activities and reporting

Supplier & Quality Administration

Maintain approved supplier and contractor records
Review supplier risk assessments
Monitor calibration and service schedules
Ensure product literature and artwork meet regulatory requirements

Experience Required

Essential

Previous experience in a Quality Assurance role
Medical Device industry experience and/or strong ISO13485 experience
Experience maintaining Quality Management Systems
Experience with internal audits
Experience managing CAPAs, complaints and non-conformances
Strong documentation and procedural writing skills

Desirable

Experience liaising with MHRA and/or Notified Bodies
ISO9001 experience
Lead Auditor qualification
Experience within a regulated manufacturing environment

Suitable Backgrounds

We would particularly like to hear from candidates currently working as:

Quality Assurance Specialist
Quality Systems Specialist
Quality Compliance Officer
Quality & Regulatory Officer
Quality Systems Coordinator
QA Engineer (Medical Devices)
Quality Manager (Medical Devices)

Not Suitable For

This role is not focused on product inspection, laboratory testing or production-based quality control. Applicants whose experience is solely within Quality Inspection or Quality Control may not be suitable.

Please note that only shortlisted applicants will be contacted

Pay: £40,000.00-£56,000.00 per year

Benefits:

Company pension
Free parking
On-site parking
Private medical insurance

Work Location: In person

Quick apply

Refine Your Search

& electronics qa engineer jobs

Quality Assurance Specialist

Senior Transaction Monitoring Officer

Document Controller

Lead Engineer

Quality Systems Specialist

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Lead (Platform) Programmer

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