Quality and Regulatory Affairs Associate (Part-Time)

Brief Job Summary:

Working within the Quality and Regulatory Affairs Team you will be responsible for supporting the Quality Management Systems within the business. This will involve ensuring compliance with ISO9001, ISO13485 and Medical Devices Regulations. You will assist in maintaining the Quality Management System (QMS) documentation supporting the quality standards, e.g. Manufacturing specifications, reference documents and review & issue of Standard Operating Procedures etc. You will support with training related to the Quality Management Systems to all levels of staff within the business and assist with investigating and managing customer complaints and respond to technical enquiries. You will assist with the management of change control in providing expertise to ensure QMS requirements are achieved. You will plan and conduct internal audits for QMS standards and follow up as directed, assisting in hosting audits by external regulatory bodies/customers as required. You will participate in continuous improvement, corrective actions and business risk minimisation and assist in initiating and maintaining supplier assessment reviews.

You will behave in a professional manner at all times, and you will build professional relationships with customers that will enhance the Company’s quality image.

ESSENTIAL CRITERIA:

• Relevant degree or diploma (e.g., in quality management, engineering, science) or equivalent experience
• Relevant industry certifications (e.g., ISO 9001, ISO13485) preferred
• Strong understanding of quality management principles and methodologies
• Proficiency in quality tools and techniques (e.g., root cause analysis)
• Experience in conducting internal audits to ISO Standards
• Excellent problem-solving and analytical skills
• Strong attention to detail and accuracy
• Excellent written and verbal communication skills
• Proficient IT skills
• Ability to build and maintain relationships with internal and external customers
• Results-oriented and proactive
• Strong organisational and time management skills
• Ability to meet deadlines and handle multiple tasks simultaneously
• Maintain accurate records with a high level of attention to detail
• Ability to work independently and as part of a team

COMPANY BENEFITS:

• Contributory Pension Scheme
• Medical Cash Back Plan
• Life Assurance
• Onsite free car parking
• Subsidised staff canteen
• Cycle to work scheme
• Employee Referral Scheme
• Free yearly flu vaccination
• Discounts on selected products and services
• Employee Assistance Programme – Health and Wellbeing