5 дней назад
Commercial Quality Senior Specialist Surgery - UK (MedTech)
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Commercial Quality Senior Specialist Surgery - UK (MedTech): Maintaining and improving the Quality Management System for the UK/Ireland Surgery organization with an accent on regulatory compliance, CAPA, audits, supplier oversight, and change control. Focus on investigating non-conformances, implementing corrective actions, supporting regulatory audits, and driving quality and process optimization across a regulated medical technology environment.
Location: Wokingham, Berkshire, United Kingdom; based at the Pinewood site until relocation to the Maidenhead site in mid-October 2026
Company
Johnson & Johnson MedTech develops surgical technologies and healthcare solutions designed to support less invasive and more personalized treatment.
What you will do
- Maintain compliance with applicable quality standards and regulatory requirements for the UK/Ireland operating companies and distribution centers.
- Own, track, and investigate non-conformances and CAPA activities using approved systems and tools.
- Conduct internal audits and support regulatory, corporate, and site audits.
- Manage change control, supplier and distributor approval, monitoring, and audit programs.
- Prepare inputs for management reviews and quality planning, and lead quality, compliance, and regulatory projects.
- Implement training programs and drive QMS simplification, standardization, and continuous improvement.
Requirements
- Bachelor’s degree in life sciences or engineering preferred.
- Experience in a quality-focused role within a highly regulated environment, preferably pharmaceuticals or medical devices.
- Knowledge of healthcare regulations and experience working with competent authorities or other regulators preferred.
- Excellent written and spoken English communication skills.
- Ability to collaborate with internal partners while working independently and escalating issues appropriately.
- Strong computer and systems knowledge, including Excel, Word, PowerPoint, Outlook, and quality systems.
Nice to have
- Experience with audit management, compliance management, quality control, quality standards, and regulatory environments.
- Digital mindset and interest in using technology, data, and automation for process optimization.
- Understanding of AI concepts, responsible AI practices, and effective prompt generation.
Culture & Benefits
- Work within a global healthcare and MedTech organization.
- Opportunity to contribute to challenging quality and business improvement projects.
- Professional development and education opportunities.
- Dynamic working environment and excellent employee benefits.
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