Senior Quality Officer

iRecruit4 are currently seeking a highly organised and detail-oriented Senior Quality Compliance Officer. In this key role, you will take responsibility and play an active part in ensuring that the Quality Assurance and Regulatory Affairs tools and processes support a fully compliant Product and Quality Management System. If you have a strong background in QA/RA, exceptional attention to detail, and a passion for upholding the highest quality standards, wed love to hear from you.

Benefits:
Competitive Pay and Profit Share Health & Wellness- critical illness cover, private healthcare Discounts on retail Hybrid- once probation is passed Full training given Professional Growth Birthdays off Company pension Opportunity to deputise for senior management, enhancing leadership skills.

About the Role:

Step into a pivotal role within a leading supplier of medical and surgical devices, renowned for delivering high-quality products and exceptional customer service. This position offers a dynamic environment where your expertise in Quality Assurance and Regulatory Affairs will be instrumental in maintaining a compliant Products and Quality Management System.

Key Responsibilities:

Promote compliance with Company and Regulatory requirements, ensuring proprietary information protection. Record and investigate Non-conformances (NCs) and Corrective and Preventive Actions (CAPAs) using root cause analysis tools. Manage NC and CAPA processes, including regular KPI reporting. Deputise for the QA/RA Manager & Responsible Person (RP) as needed. Support the implementation and maintenance of a Quality Management System (QMS), including quality risk management, documentation management, and internal audits.

Review documentation for accuracy and compliance with cGDP and MDD/MDR. Support the supplier assurance programme and the Labour Standards Assurance Scheme (LSAS). Participate in regulatory and customer audits, and maintain knowledge of site policies and procedures. Candidate Profile:
Proven experience in a Quality Assurance role within the medical device or pharmaceutical industry. Qualified Internal Auditor with a thorough understanding of ISO
13485, ISO
9001, MDD/MDR, GDP, ISO
27001, and LSAS requirements. Proficient in Windows applications (Word, Excel, etc.). Strong interpersonal skills with the ability to challenge behaviours appropriately. Excellent time management and the ability to work under pressure with a flexible attitude. Capable of analysing data and generating comprehensive reports. Effective communication skills, both oral and written. Ability to work independently and as part of a team, liaising confidently with staff, suppliers, and customers at all levels.

This role is ideal for a motivated professional looking to make a significant impact within a reputable company. If you possess the required skills and experience, this could be the next step in your career.