Quality Regulatory Assurance Lead - Flexible Hours & Audits

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

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