Senior QA Specialist

Advanced Sterilization Products; United Kingdom; Remote; GBP 40,000 - 65,000; Full time

Job summary

A leading company in medical devices is seeking a Senior Quality Assurance Specialist to oversee compliance and audit activities across EMEA and APAC regions. The role involves maintaining QMS, conducting internal and external audits, and leading audit responses. The ideal candidate will have a Bachelor's degree, at least 5 years of QMS experience, and knowledge of relevant medical standards.

Benefits

Inclusive benefits

Flexible schedules

Parental leave

Qualifications

• At least 5 years in QMS and auditing.
• Knowledge of ISO13485:2016, FDA CFR 820, EUMDR, MDSAP standards.

Responsibilities

• Owns Inspection Readiness program ensuring continuous compliance.
• Perform Internal and Supplier Audits including planning and reporting.
• Lead External Audits and Health Authority notification responses.

Skills

Auditing expertise

Knowledge of Medical Device Standards

Strong communication skills

Fluent in English

Education

Bachelor's Degree

Job description

Social network you want to login/join with:

Senior QA Specialist, remote, UK

Client:

Advanced Sterilization Products

Location:

Remote, UK

Job Category:

Other

EU work permit required:

Yes

Job Reference:

5043d12e144b

Job Views:

21

Posted:

18.06.2025

Expiry Date:

02.08.2025

Job Description:

Role

This is an extraordinary career opportunity for a Senior Quality Assurance (QA) Specialist responsible for supervising and leading activities to ensure continuous compliance. You will work with internal and external partners mainly in EMEA and APAC regions for audits, ensuring departments are prepared for external inspections to minimize compliance risks.

Location: Europe - remote

How you will contribute to ASP:

• Owns the Inspection Readiness program to ensure the QMS operates in continuous compliance, including training, site visits, and corrective actions.
• Perform Internal and Supplier Audits, including planning, execution, reporting, and follow-up.
• Conduct External Audits and Inspections.
• Lead Health Authority notification responses.
• Maintain QMS and product certificates, manage audit reports and metrics.
• Research regulatory trends and participate in industry events.
• Guide auditors-in-training and evaluate processes for improvements.
• Perform special projects as needed.

What will make you thrive in this role:

• Bachelor's Degree
• At least 5 years in QMS and auditing
• Knowledge of Medical Device Standards (ISO13485:2016, FDA CFR 820, EUMDR, MDSAP)
• Auditing expertise
• Fluent in English
• Strong communication skills
• Ethical, adaptable, committed to continuous improvement

We value diversity and offer inclusive benefits, flexible schedules, parental leave, and more.

Our Culture

Our ASP culture is rooted in our ASPirational4 values: customer obsession, courage, teamwork, and results. We are committed to continuous improvement, facing challenges, speaking openly, and working sustainably. We celebrate successes and learn from failures together.