Senior Quality Systems Lead - Regulatory Excellence

Stryker Group; Belfast; On-site; GBP 45,000 - 60,000; Full time

Job summary

A global medical device company is seeking a Senior Quality Systems Specialist in Belfast to lead quality system improvement projects and ensure regulatory compliance with FDA and ISO standards. The ideal candidate will have a Level 6 qualification in a relevant field and at least 3 years of experience in a manufacturing environment. Strong skills in project management, technical writing, and effective communication are essential for success in this role, making a significant impact on quality systems across the organization.

Qualifications

• Minimum of 3 years experience in manufacturing environment or equivalent preferred.
• Understanding of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.

Responsibilities

• Lead quality system improvement projects based on internal assessments.
• Map and analyze quality processes to identify improvement priorities.
• Collaborate across departments to implement quality improvements.
• Support audits by providing complete and accurate documentation.

Skills

Experience in regulated environment and interaction with regulatory agencies

Strong knowledge of Quality Systems (CAPA, audits, etc.)

Excellent technical writing and documentation skills

Strong communication and project management skills

Analytical and problem-solving capabilities

Ability to plan, organize, and implement multiple tasks

Education

Level 6 qualification in Science, Engineering, Business or related discipline

Tools

Microsoft Office

MS Project

Adobe Acrobat

Job description

A global medical device company is seeking a Senior Quality Systems Specialist in Belfast to lead quality system improvement projects and ensure regulatory compliance with FDA and ISO standards. The ideal candidate will have a Level 6 qualification in a relevant field and at least 3 years of experience in a manufacturing environment. Strong skills in project management, technical writing, and effective communication are essential for success in this role, making a significant impact on quality systems across the organization.