This job is no longer available. Please search for new vacancies here or register an account to upload your CV.

To view more technical engineering jobs click here.

Quality Assurance Manager

  • Reference IP30653-RA
  • Salary £40,000 - £60,000
  • Location Ebbw Vale
  • Job type Permanent

An industry leading manufacturer to the medical/life science industries currently require a Quality Assurance Manager to join their team. This is an exciting opportunity to join a global business involved in innovative and sustainable technology.

As an experienced QA Manager, you will be responsible for risk management and the daily hands on management of the company’s manufacturing QMS (quality management system) - ISO 13485, taking an active role in developing and maintaining the company’s regulatory and compliance activities to new and existing products.


Responsibilities:

Maintain, manage and own the QMS (ISO 13485) to ensure all manufactured products and technical files meet specifications.
Work with operations and logistics teams to manage production issues where Quality functional support is required.
Ensure compliance standards are understood and met for equipment, facilities, processes and products.
Monitor and advise on how the business and QMS is performing (KPI’s etc).
Be the responsible person for communication with authorities and bodies and for audits and inspections
Working closely with colleagues at all levels to provide training and support.
Audit key suppliers for risk reduction and supplier selection.
Support the commercial team where required
Deal with customer complaints or feedback
Report and close out non-conformances and generate corrective actions (8D / CAPA)
Support the R&D teams with NPI


Experience/Skills:

Experience of establishing, maintaining and managing quality systems within a medical manufacturing or laboratory environment, ISO 13485 / cGMP is desirable.
Science or engineering degree preferred but not essential
Solid experience in writing functional procedures and work instructions.
A broad knowledge and understanding of appropriate manufacturing methods, process management and associated activity.
Excellent communication skills both written and oral.
Analytically minded, with some project management, validation or regulatory experience or willing to train in these areas.
Good auditing experience
Strong team ethic, cross functional mindset, able to work well under pressure
A hands-on role offering excellent potential within an innovative, growing business with significant global presence.

Sign up for industry updates