Quality Engineer

Location: Quedgeley, Gloucestershire, England
Salary: £40k per year
Reference: 4505
Contact Name: Maria Thorne
Expiry Date: 2022-07-10

Quality Engineer

Location: Gloucester

Hours of work: 39 hours, Monday to Friday

Salary: £35,000 - £40,000

Job Purpose:

  • To maintain and support the quality management systems within a medical device ISO 13485, manufacturing environment.
  • Maintains product quality standards across all manufacturing processes, focusing on those where deficiencies are known/occur. Supports teams to work accurately and effectively to eliminate/reduce the probability and severity of faults, failures and scrap.
  • Working as part of a team which strives to define and develop manufacturing solutions from the early phases through to production working with the Engineering team. This will include working as part of a project core team with respect to design control, as well as working with the operational team on continuous improvement projects.

Key Responsibilities:

  • Maintaining the efficiency of the Quality Management System (QMS) and implementing continuous improvement.
  • Maintaining processes and creating procedures related to incoming inspection, quality assurance and quality compliance.
  • Work with the Technical teams to ensure the proper deployment of Engineering Changes.
  • Plan and carry out Process Validation for existing and new products.
  • Qualified as an internal auditor. Part of the internal quality audit team by auditing the quality and manufacturing processes to ensure both internal and external regulations.
  • Maintain working knowledge of Regulatory and Quality System requirements.
  • Support customer & 3rd party audits, including yearly QMS audit.
  • Writing and updating documentation for maintenance of the quality management system.
  • Contribute to CAPA system, complaint management process and documentation control.
  • Train and provide assistance to the other QA teams on quality procedures, protocols, and documentation.
  • Coordinate investigation of quality issues with customers and suppliers

Experience, attributes & skills sought:

  • Scientific or engineering degree with experience in the medical device or pharma industry, in a quality related position.
  • Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
  • Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745.
  • Project management desirable
  • Formulating and execution of corrective action programs

In return, you will benefit from:

      25 days' holidays plus bank holidays

Pension - Nest

Single Vitality Healthcare - upon successful completion of the probationary period

Perkbox

Closing date is 12 th July 2022

Hawk 3 Talent Solutions are operating as an employment agency on behalf of its client.

To Apply please follow the application process for the site this job is advertised on or email your CV to Rachel.wilson@hawk-3.com. By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. To view our full Privacy Policy please visit our website.

Hawk 3 Talent Solutions are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future

Hawk 3 Talent Solutions s committed to the selection, recruitment and development of the best people, basing judgments solely on suitability for the job. By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future.