Hybrid Senior Quality Systems Lead — FDA/ISO Compliance

Stryker Corporation; Belfast; Hybrid; GBP 60,000 - 80,000; Full time

Job summary

A leading medical device company in Belfast is seeking a Senior Quality Systems Specialist to lead quality system improvement activities and ensure compliance with FDA and ISO regulations. The ideal candidate will have at least 3 years of experience in a manufacturing environment, strong knowledge of quality systems, and excellent communication skills. Key responsibilities include mapping existing processes, supporting audits, and collaborating with various teams to implement improvements. This role offers a hybrid work flexibility.

Qualifications

• Minimum of 3 years experience in a manufacturing environment or equivalent preferred.
• Demonstrated ability to work in cross-functional team environments.
• Ability to plan, organize, and implement multiple concurrent tasks.

Responsibilities

• Lead improvement projects related to quality system opportunities.
• Map existing quality processes to identify improvement priorities.
• Partner cross-functionally to implement sustainable quality improvements.
• Support internal and external audits by providing documentation.

Skills

Experience in regulated environment

Understanding of FDA 21 CFR Part 820

Strong knowledge of Quality Systems

Excellent technical writing skills

Strong communication skills

Education

Level 6 qualification in Science, Engineering, or Business

Tools

Microsoft Office

MS Project

Adobe Acrobat

Job description

A leading medical device company in Belfast is seeking a Senior Quality Systems Specialist to lead quality system improvement activities and ensure compliance with FDA and ISO regulations. The ideal candidate will have at least 3 years of experience in a manufacturing environment, strong knowledge of quality systems, and excellent communication skills. Key responsibilities include mapping existing processes, supporting audits, and collaborating with various teams to implement improvements. This role offers a hybrid work flexibility.