Hiring Now: Quality Assurance Specialist Near You – Apply Today!

Your Next Quality Assurance Specialist Job Starts Here – Apply Now!

Quality Assurance Specialist

Job Posted: a month ago

Salary: £ Competitive
Job Type: Permanent
Location: OL10, Crimble, Borough of Rochdale

Expire in: a day

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
AND/OR
✔ 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
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

Before You Apply

Do not include the following in your job application, CV, or cover letter:

Bank details.
National Insurance number.
Date of birth.

You should not be asked for payment or irrelevant information. If you have concerns about a job advert or employer, seek guidance on how to proceed.

Looking for your next career move? Join a top company hiring Quality Assurance Specialist job near me in OL10, Crimble, Borough of Rochdale! This is your chance to work on exciting projects, grow professionally, and enjoy a rewarding career with competitive pay and excellent benefits. Whether you're an experienced professional or looking to take the next step, this role offers the perfect opportunity to enhance your skills and make an impact. Don’t miss out—apply today via Vita CV and take your career to the next level!