Project Quality Engineer

Job description
Job Role:

Reporting to The West Group Quality & Regulatory Manager, you will support the Quality department by driving Product and Quality System projects. You will actively promote Quality throughout the organisation and assist in achieving company and departmental objectives, targets, and measurements.

Job Responsibilities:
• Act as an ambassador for the company, promoting a positive image both internally and externally, and demonstrating support for our strategic direction.
• Collaborate with the Quality and Regulatory Manager on Quality Projects, including QMS Projects, Supplier reviews, and Engineering Projects.
• Work closely with customers to address Non-Conformances, ensuring issues are understood and containment, corrective, and preventative actions are provided promptly.
• Investigate quality-related issues internally and with customers, identifying root causes and implementing corrective actions (8Ds).
• Drive cross-functional investigations of non-conformities using problem-solving methodologies such as 8D/5Y/Ishikawa.
• Develop and implement Master Validation Plans & Quality Control Plans for selected new products.
• Conduct Gage R&R activities as required.
• Support the creation of FMEAs as needed.
• Conduct routine, new, or development Supplier Audits to ensure conformity to West Group standards and expectations.
• Work with suppliers to close Audit NCs and re-audit if necessary to ensure completion.
• Complete Internal Audits as required.
• Liaise with other departments to improve Internal QMS Procedures and Documents as necessary.
• Actively promote Continuous Improvement (CI) within the business and the team.
• Participate in relevant Kaizen events to promote Continuous Improvement.

Required Job Skills:
• HNC equivalent or higher in relevant engineering (Essential)
• Knowledge of ISO13485 and experience with medical devices (Desirable)
• Internal Auditor Experience (Desirable)
• Strong communication and interpersonal skills