Overview

Salary: up to £65,000

Location: Onsite / Hybrid

Commutable From: Sheffield, Leeds, York, Manchester, Burnley

The Company

An exciting opportunity to work for a medical device company based in North England is now available for a Quality Assurance Engineering Manager. This is a new position as the company is currently going through a restructure with clear, defined goals.

The Role

The client is looking for an experienced hands-on Quality leader who has demonstrated experience in strategy execution and driving improvements in quality processes in line with the ISO13485 QMS. In addition, the successful candidate will be responsible for overseeing and ensuring compliance within quality standards and regulations for development and manufacturing and distribution. This role requires the candidate to be a critical thinker and have a strong engineering background where problem solving and improving process is paramount. You will be working closely with cross functional teams, conducting audits and implement CAPAs to ensure the highest level of product quality and patient safety. The successful candidate will also have demonstrated experience in leading and managing a team of quality professionals, providing guidance, training and support to ensure effective quality operations.

Key Skills

• Quality Engineering (Lean Six Sigma – Highly Desirable)
• ISO13485
• CAPA , NCRs
• Process Improvement
• Root Cause Analysis
• FMEA
• Audit Experience (Front End / Back End)
• Cleanroom Experience