Quality Manager

Cardiff CF14

Commutable from Cardiff, Bridgend, Newport, Caerphilly, Pontyclun, Barry, Penarth, Pontypridd

£47,000

Benefits:-

• 10% Bonus
• 25 Days holiday plus bank holidays rising to 28 with service
• 6% Pension Scheme
• Hybrid working
• Sick Pay package
• Death in service
• Onsite parking
• Excellent training and long term development opportunities

A Cardiff based, international business are looking to recruit a Quality Manager on a fixed term contract due to a maternity. This business excel in their field and their product has a genuine impact on the end user. The business offer an excellent benefits package including a strong pension contribution, a good bonus and opportunities to go on courses and further professional development. The role is well suited to an engineer coming from a highly regulated industry who is looking to step up into management.

Role & Responsibilities:

• Manage a team of QMS Co-Ordinators
• Chair and facilitate the Group Change Control Program, in line with business procedural requirements
• Support New Product Development activities as required
• Lead & Professionally represent at all external agency & customer inspections
• In conjunction with the Quality & Regulatory Department, provide input and support decisions regarding the execution of any Field Safety Corrective Actions (FSCA).
• Deliver relevant Internal quality assurance training for departments
• Responsible for ensuring the Quality Management System is maintained to deliver compliance and aligns with assigned KPI
• Support both the Internal and Supplier audit schedule, conducting Inspections when assigned
• Measure and trend Documentation and Change Control Programs against agreed

Knowledge, Skills & Experience:

• Significant experience in a Quality Engineer role
• Experience in Medical Device or IVD environment working to ISO Standards and FDA CFR in a continuous improvement environment
• Significantly strong communication skills, both verbal and written
• SME for eQMS
• Understanding of ISO 13485, ISO 14971, ISO11135, EN980 MDD 93/42/EEC and MDR 2017/45

26171/617

To apply please email your CV / resume to jackl@hunterselection.co.uk