Quality Regulatory Assurance Lead

Noxbox Ltd.; Swanley; On-site; GBP 55,000 - 75,000; Full time

Benefits offered by this job

25 days holiday + bank holidays

Private health insurance

Pension plan

Life assurance

Job summary

NOxBOX Ltd, a subsidiary of Linde, seeks a Quality Regulatory Assurance Lead to manage QA activities, audits and regulatory compliance for its medical device operations in Sittingbourne, Kent, GB. You will guide a small QA team through registration, document control, CAPA, and investigations, ensuring top quality and safety standards.

The role emphasizes internal audits, regulatory alignment, and health and safety support within a regulated industry, with opportunities to influence quality

Qualifications

• Degree in technical/engineering/science or equivalent with 5+ years in a similar role.
• Experience or training in internal audit techniques aligned to ISO 13485.
• Analytical and problem-solving skills.
• Strong attention to detail.
• Experience in a regulated industry (medical devices or similar) in a quality/technical role.
• Ability to prioritize workload and plan tasks to meet schedules.
• Excellent written and verbal communication skills; able to work independently and in a team.

Responsibilities

• Manage day-to-day responsibilities and support a small QA team covering Registration, Document control, training, Product release, Non-conformance and CAPA, and Complaints processes.
• Coordinate complaint handling activities and support investigations with operations and engineering teams, and the parent company Quality Unit.
• Maintain processes for regulatory compliance of products on the market.
• Coordinate the Internal Audit program including schedules, audits, reports and action progression.
• Keep awareness of relevant international standards, regulations and guidance; perform reviews and update processes as required.
• Support Health and Safety activities across the organisation, ensuring compliance with the NBL Health and Safety Policy.

Skills

Internal audit

Analytical skills

Attention to detail

Regulated industry experience

Communication skills

Prioritization

Teamwork

Education

Degree in technical/engineering/science

Job description

What you will enjoy doing

• You will manage day to day responsibilities and support a small QA team performing Registration, Document control, training, Product release,Non-conformance and CAPA, and Complaints processes
• You will cordinate complaint handling activities, support investigations with operations and engineering teams, and parent company Quality Unit
• Maintaining the processes for ongoing regulatory compliance of product on market will be part of your role
• Further, you will coordinate the Internal Audit program including preparing and monitoring schedules, conducting audits preparing reports and progressing actions
• You will maintain awareness of relevant international standards, regulations and guidance, ensuring current practice, performing reviews and updates to processes where required
• Supporting Health and Safety activities across the organisation, ensuring compliance to the NBL Health and Safety Policy will be part of your role

What makes you great

• You own a qualifications such as a degree in a technical/engineering/science discipline, or equivalent experience such as 5 or more years’ experience in a similar role
• You are ideally trained or experienced in internal audit techniques aligned to ISO 13485
• Analytical and problem-solving skills suits your profile
• You have good attention to detail
• You have experience of working in a regulated industry, medical devices or similar and in a quality or technical role
• Ability to prioritize workload, and plan tasks and time to meet schedules and project timeframes suits your profile
• Further you have excellent written and verbal communication skills and are able to work independently and as part of a team

Why you will love working with us

NOxBOX Ltd, a subsidiary of leading global industrial gases and engineering company Linde, specializes in inhaled nitric oxide delivery and monitoring instruments for the medical market.NOxBOX manufactures and distributes medical ventilators, which can be found in hospitals around the world. These de-vices are used primarily in neonatal wards and NICUs to sup-port babies and infants with their breathing and have also been relied upon during the global Covid-19 pandemic.

What we offer you!

We are a small, elite team who work together to ensure flexibility for our employees and their families. We offer flexible start times and an early finish on Fridays. We have 25 days holiday + bank holidays. Other benefits include competitive salaries, private health insurance, pension plan, life assurance, and more.

Any designations used of course apply to persons of all genders. The form of speech used here is for simplicity only.
NOxBOX Ltd. acts responsibly towards its shareholders, business partners, employees, society and the environment in each of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.

Quality Regulatory Assurance Lead • Sittingbourne, Kent, GB