Quality Assurance Manager

Staffline; Gloucester; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

25 Days + Bank Holidays

Private Health Care Options

Competitive pension contribution

Employee benefits platform for retail

Job summary

Staffline is seeking a Quality Assurance Manager to lead the QA function at our Gloucester site. You will ensure products meet the highest quality standards and drive continuous improvement within the QMS.

You will oversee audits, investigations and change control, maintain ISO 13485 compliance, and collaborate with engineering and manufacturing teams to deliver compliant, safe products.

Qualifications

• Degree in engineering, medical technology, or equivalent.
• Knowledge of ISO 13485 and FDA QSR required.
• Experience with quality tools (8D, CAPA, 5 Why, PDCA, 5S).
• Experience with complaint investigations and resolution.

Responsibilities

• Lead and ensure processes meet highest quality standards.
• Develop, implement and maintain QA processes and QMS.
• Oversee quality investigations, internal audits and change management.
• Maintain ISO 13485 certification.

Skills

ISO 13485 knowledge

FDA QSR knowledge

Quality management

Education

Degree in engineering / medical technology or equivalent

Tools

ISO 13485

FDA QSR

8D

CAPA

5 Why

PDCA

5S

Job description

Position: Quality Assurance Manager
Location: Gloucester, Gloucestershire
Job Type: Permanent / Onsite

My client, a global manufacturing business are on the hunt for a QA Manager to head up the Quality Assurance function of the business.

Role and Responsibilities

In this role, you will lead and make sure that the companies processes ensure their products meet the highest standards of quality.

Other responsibilities include:

• Responsible for developing, implementing and maintaining Quality assurance processes
• Ensure efficient, effective and compliant QMS process
• Overseeing compliant investigations, internal audits and change management
• Look to maintain the ISO13485 certification

Experience or Qualifications

• Degree educated in a relevant subject associated to engineering, medical technology or equivalent
• Knowledge of ISO 13485 Quality System and FDA Quality System requirements essential
• Experience of Quality Tools including 8D, CAPA, 5 Why, PCDA and 5S
• Experience of complaint investigation and resolution

Benefits

• 25 Days + Bank Holidays
• Private Health Care Options
• Competitive pension contribution
• Employee benefits platform for retail discounts

Candidates who currently are a Quality Assurance Manager, Quality Manager, QA Manager or QMS Manager may be suitable for this position.