SKILLS/COMPETENCIES

• Knowledge of quality systems e.g., ISO9001, ISO13485, MDD/MDR, CFR Part 820 & ISO14971
• Experience of applying Quality Tools and Techniques within a relevant industry – e.g. FMEA, RCA, CAPA, 8D, APQP, 5 Why, MSA, Statistical Analysis (Minitab)
• Excellent communication skills, both written and verbal
• Strong organisational and time management skills and ability to manage own workload independently
• Knowledge and experience in the generation and maintenance of Product Technical Files (CE / UKCA)
• Experience of applying Lean Six-Sigma tools and techniques

KNOWLEDGE, EXPERIENCE, QUALIFICATIONS

• Qualified in an engineering or technical discipline
• Experience working within a regulated industry

MAIN JOB PURPOSE

Support the Quality Manager and Regulatory Affairs Manager to drive continuous improvement and develop / maintain Quality throughout all stages of the product Lifecycle.

KEY RESPONSIBILITIES

• Serve as the primary Quality Assurance liaison for both customers and internal teams regarding a designated portfolio of products
• Support Europlaz and customer-led validation and verification activities, ensuring timely and successful completion. Leverage process outputs to define in-process inspection criteria, including sample size, frequency, and related quality controls
• Support the Regulatory Affairs Manager to create and maintain product Technical Files in accordance with requirements
• Maintain and improve the company’s Quality Management System and internal processes
• Lead targeted problem-solving activities to address specific problems as and when they arise during development and in production
• Lead Change Management activities ensuring robust adherence to all processes and applicable requirements
• Support adherence to the company’s Internal and Supplier Audit schedules and the implementation of robust actions to address and follow up on any issues raised
• Act as an ambassador for Quality throughout all levels of the business. Help to ensure requirements are understood and participate in coaching and training activities as required
• Other various quality-based tasks as directed by the Quality Manager