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Job Title: Quality Auditor
Job Type: Permanent Full Time
ABOUT THE COMPANY:
A fast-growing, international medical device company committed to advancing organ transplantation and improving patient outcomes globally are seeking a Quality Auditor to strengthen their Quality Assurance team.
Position Summary:
As a Quality Auditor, you will play a key role in conducting internal and supplier audits to ensure compliance with our Quality Management System (QMS), regulatory requirements, and industry best practices. You will be responsible for identifying areas of improvement, supporting continuous improvement initiatives, and helping ensure the safety and effectiveness of our products. This role requires significant collaboration across teams and suppliers and offers the opportunity to make a meaningful impact on the quality and reliability of life-saving medical technologies.
Key Responsibilities:
* Plan and execute internal audits and supplier audits per regulatory standards (e.g., ISO 13485:2016, FDA 21 CFR Part 820, EU MDR).
* Maintain and deliver audit schedules, ensuring timely execution and reporting.
* Evaluate internal QMS processes and supplier systems for compliance and performance.
* Identify and support the implementation of corrective and preventive actions.
* Generate audit reports, communicate findings to stakeholders, and track resolution effectiveness.
* Assist with supplier qualification, re-evaluation, and quality assessments.
* Participate in external audits and inspections (e.g., by regulatory bodies or notified bodies).
* Collaborate closely with suppliers to drive quality improvements and compliance.
* Stay informed of evolving regulations and standards; support training efforts internally.
Skills & Experience:
* Interpersonal & Communication: Able to foster respectful, collaborative relationships with audit stakeholders; able to clearly communicate audit findings and facilitate open dialogue.
* Critical Thinking: Strong analytical skills and a proactive approach to identifying improvement opportunities beyond basic compliance.
* Technical Tools: Proficiency in Microsoft Office (Excel, Word, PowerPoint, Visio, Access); experience with QMS platforms such as MasterControl is a plus.
* Organizational Abilities: Highly organized, detail-oriented, and capable of managing multiple priorities effectively.
* Audit Expertise: Experience conducting quality system audits; lead auditor certification (ISO 13485, MDR, MDSAP) preferred.
Qualifications:
* Education: Bachelor’s degree in a science, quality, regulatory, or related field (or equivalent experience).
* Experience: Minimum 3 years of experience auditing within a medical device quality system or a similar regulated environment.
* Regulatory Knowledge: In-depth understanding of FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR 2017/745, and MDSAP; familiarity with upcoming regulatory changes is a plus.
* Communication: Strong written and verbal skills; comfortable engaging with diverse teams and external partners.
* Travel: Willingness and ability to travel 10–15%.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Quality Assurance
* Industries
Medical Equipment Manufacturing
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