Sector: Life Sciences
Consultant: Chris Hutchinson
Salary: £25000 - £35000
Job Status: Permanent / Full Time
I am currently looking for a suitably experienced Quality Assurance Officer, with the energy and drive to implement quality improvement & regulatory compliance across my clients business. I would need a self-starter who can schedule and plan their own work. A working knowledge of quality management standards in a regulated environment would be beneficial (e.g. ISO13485 / ISO9001 quality management systems
Quality / Regulatory
Implementation and maintenance of ISO13485 / ISO9001 quality management system
Internal / supplier audits
Handling & disposition of product – process nonconformity
Measurement, analysis & improvement including corrective and preventive actions
Maintenance & update of quality documentation (Specifications / Procedures)
Product – process qualification/validation and the writing of suitable protocol & test reports.
Complaint handling & investigation. Medical device vigilance procedures.
Preparing quality data for the management team.
Primary contact / liaison with regulatory authorities
Maintenance of Medical Device Files
Quality review of specifications & reports
General support documentation for our sales team and distributors.
A minimum of 2 years’ experience working in the medical device sector or similar regulated industry.
A good standard of education (A-levels or equivalent).
Capable of preparing, reviewing and maintaining quality documentation and records.
Some travel will be required to fulfil the role.
The company is looking to pay £25,000 up to £30,000 pension and health insurance package