Halian is seeking a highly skilledSenior Design Quality Engineerto 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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