Halian is seeking a highly skilled Senior Design Quality Engineer to join a leading global medical device business based in Kent. This is a fantastic opportunity to contribute to the development of life-saving technologies while ensuring compliance with international quality and regulatory standards.

Key Responsibilities

Lead quality assurance activities across product development and manufacturing. Ensure compliance with ISO 13485, ISO 14971, 21 CFR Part 820, and other relevant standards. Act as the Quality Core Team Member, embedding quality into every stage of product design and realisation. Apply advanced quality tools including risk management, design controls, verification and validation, CAPA, and statistical analysis. Support regulatory compliance efforts, including audit readiness and responses to global regulatory bodies. Develop and maintain product risk management files in accordance with ISO 14971. Collaborate with cross-functional teams to manage product changes, participate in design reviews, and support design transfers. Monitor global product data to identify trends, risks, and opportunities for improvement. Provide guidance on resolving on-market product issues and escalate critical concerns to senior leadership. Contribute to special projects and continuous improvement initiatives.

Skills & Experience

Strong understanding of Quality Management Systems and their integration with risk management, CAPA, complaints, and document control. In-depth knowledge of medical device regulations and standards. Proven ability to conduct complex investigations and apply systems thinking across hardware, software, and consumables. Analytical mindset with the ability to interpret data and identify patterns leading to actionable insights. Effective collaboration with engineering and manufacturing teams.

Qualifications

Bachelors degree in Engineering (Electrical, Mechanical, Biomedical, Software) or a related field. Minimum 7 years of experience in R&D or Quality within the medical device industry. ASQ Certified Quality Engineer (CQE) certification required or must be obtained within one year.

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