Quality Systems Leader, Regulatory Compliance

ECI; Chipping Norton; On-site; GBP 91,000 - 136,000; Full time

Job summary

ECI in the life sciences sector is seeking a Principal Quality Systems Engineer to join the Regulatory Compliance Work Stream. You will establish Quality Systems with emphasis on 21 CFR 820 and ISO 13485, guiding clients through regulatory requirements and best practices.

You will lead quality systems initiatives, develop SOPs and audit plans, and ensure compliance with national and international standards across client engagements.

Qualifications

• Bachelor’s degree in engineering or equivalent work experience.
• Minimum of 10 years of directly related experience in Quality Systems in a regulated environment.
• Experience conducting audits with focus on standard and process compliance; familiarity with FDA/Notified Body processes is desirable.
• SME level understanding of ISO 9001, 13485, 14971, 21 CFR 820/210/211/11; CQA certification is highly desirable.

Responsibilities

• Lead quality systems related projects and serve as a company champion towards client quality improvement initiatives.
• Develop, implement and audit Quality Management Systems policies and procedures at client sites.
• Write and refine QMS SOPs, risk management documents and related training materials.
• Coordinate audits and assist clients during national and international regulatory reviews.

Education

Bachelor’s degree in engineering

Tools

Agile PLM

Job description

ECI in the life sciences sector is seeking a Principal Quality Systems Engineer to join the Regulatory Compliance Work Stream. You will establish Quality Systems with emphasis on 21 CFR 820 and ISO 13485, guiding clients through regulatory requirements and best practices.

You will lead quality systems initiatives, develop SOPs and audit plans, and ensure compliance with national and international standards across client engagements.