Our client, an innovative medical device business based near Fareham in Hampshire, is seeking a Quality Engineer to support the development and continuous improvement of its Quality Management System. Working within a growing medical technology environment.
This permanent, hybrid position is focused on quality systems, compliance and auditing. The successful applicant will help maintain audit readiness, support regulatory compliance and embed practical quality processes across the business.
Key Responsibilities:
Maintain and improve digital and paper-based elements of the Quality Management System
Plan, conduct and report on internal audits
Lead external audit readiness, including evidence packs, responses and follow-up actions
Support compliance with ISO 13485 and quality risk activities aligned with ISO 14971
Apply knowledge of ISO 9001 and quality engineering principles within a regulated medical device environment
Manage controlled updates to procedures, forms and quality records
Support CAPA and continuous improvement activities arising from audits and quality findings
Lead Quality improvement projects
Work collaboratively with stakeholders to establish consistent and effective quality practices
Job Requirements:
Experience in Quality Engineering or Quality Compliance within the medical device sector
Strong working knowledge of ISO 13485 and an understanding of ISO 14971
Knowledge of ISO 9001, quality management systems and regulatory compliance
Experience supporting internal and external audit cycles for medical device products
Understanding of CAPA, document control, quality risk management and continuous improvement
Confidence working in a regulated, evolving scale-up environment
Clear communication skills and the ability to work effectively with stakeholders across the business
Strong attention to detail with a structured and practical approach to quality assurance
Benefits:
Hybrid working arrangement in Whiteley, Hampshire
27 days' holiday, plus bank holidays and an additional day per year
40-hour working week
5% pension match
Share scheme
Cycle to work scheme
Dental scheme and company lunch on Thursdays
If you are an experienced Quality Engineer with medical device, quality systems and audit experience, this is an excellent opportunity to support the growth of an innovative healthcare technology business. Apply now to take the next step in your career
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