Senior Quality Leader – UK, Ireland & Nordics (Hybrid)

Boston Scientific Gruppe; Hemel Hempstead; Hybrid; GBP 55,000 - 75,000; Full time

Job summary

A global medical technology company in Hemel Hempstead is seeking a Senior Quality Specialist to ensure product safety and compliance across the UK, Ireland, and Nordic regions. The role involves maintaining the Quality Management System, leading audits, and resolving quality issues. Ideal candidates have at least 5 years of relevant experience, particularly with ISO 13485. This position offers hybrid working with meaningful projects that improve patient safety.

Benefits

Competitive salary

Benefits package

Professional growth opportunities

Hybrid work options

Qualifications

• Minimum 5 years of experience in Quality System Management within the medical device or pharmaceutical industry.
• Proven experience with ISO 13485 and related regulatory frameworks (FDA, EU MDR).
• Demonstrated ability to lead audits, manage CAPA processes, and improve documentation controls.
• Experience in distribution centre and logistics quality oversight.

Responsibilities

• Maintain and improve the Quality Management System (QMS).
• Lead audits and act as the subject matter expert during inspections.
• Manage product recalls and advisory notices.
• Investigate and resolve quality issues.
• Collaborate with cross-functional teams to ensure understanding of quality requirements.
• Drive continuous improvement projects.
• Mentor junior Quality team members.

Skills

Quality System Management

ISO 13485

CAPA processes

Stakeholder management

Communication skills

Job description

A global medical technology company in Hemel Hempstead is seeking a Senior Quality Specialist to ensure product safety and compliance across the UK, Ireland, and Nordic regions. The role involves maintaining the Quality Management System, leading audits, and resolving quality issues. Ideal candidates have at least 5 years of relevant experience, particularly with ISO 13485. This position offers hybrid working with meaningful projects that improve patient safety.