Quality Regulatory Assurance Lead

BOC UK & Ireland; Sittingbourne; On-site; GBP 60,000 - 80,000; Full time

Benefits offered by this job

Flexible work options

25 days holiday + bank holidays

Private health insurance

Job summary

NOxBOX Ltd in Sittingbourne, United Kingdom, seeks a Quality Regulatory Assurance Lead to oversee day-to-day QA activities including Registration, Document Control, training, Product Release, Non-conformance and CAPA, and Complaints handling, plus supporting Internal Audits and regulatory compliance.

The role requires a technical/engineering/science degree (or equivalent), ISO 13485 audit exposure, strong analytical skills, attention to detail, and experience in regulated medical devices.

Qualifications

• Degree in a technical/engineering/science discipline or equivalent experience.
• Ideally trained/experienced in internal audit techniques aligned to ISO 13485.
• Analytical and problem-solving skills suited to the role.
• Good attention to detail.
• Experience in a regulated industry, medical devices or similar, in a quality/technical role.
• Ability to prioritise workload and plan tasks to meet deadlines.
• Excellent written and verbal communication skills; able to work independently and in a team.

Responsibilities

• Manage day-to-day QA activities: 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 Quality Unit.
• Maintain processes for ongoing regulatory compliance of products on the market.
• Coordinate Internal Audit program: schedules, audits, reports, and action tracking.
• Maintain awareness of relevant international standards, regulations and guidance; update processes as required.
• Support Health and Safety activities and ensure compliance with policy.

Skills

Analytical thinking

Problem solving

Attention to detail

Communication skills

Team collaboration

Time management

Education

Technical/engineering/science degree

Job description

NOxBOX Ltd.

Quality Regulatory Assurance Lead

Sittingbourne, United Kingdom | req33235

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.