Medical Device Auditor
Position: Medical Device Auditor - ISO 13485
Location: Poland (Remote with Travel)
Employment Type: Full-Time
About Us:
We are a globally recognised Notified Body renowned for our commitment to excellence in medical device certification. Our organisation has a proven track record of successfully supporting numerous clients in achieving and maintaining compliance with international standards.
Role Overview:
As a Medical Device Auditor, you will play a pivotal role in assessing and ensuring compliance of medical device manufacturers with ISO 13485 standards and relevant regulatory requirements. Your expertise will contribute to the safety and efficacy of medical devices in the global market.
Key Responsibilities:
Plan, conduct, and report on audits of medical device manufacturers' Quality Management Systems (QMS) in accordance with ISO 13485, MDR, and other applicable regulations.
Evaluate technical documentation and risk management files to ensure compliance with regulatory standards.
Provide clear and constructive feedback to clients, guiding them towards continuous improvement.
Collaborate with cross-functional teams to maintain the integrity and consistency of audit processes.
Stay abreast of changes in medical device regulations and standards to ensure up-to-date auditing practices.
Qualifications:
Bachelor's degree in Engineering, Biomedical Science, or a related field.
Minimum of 3 years' experience in auditing medical device manufacturers against ISO 13485 standards.
Comprehensive knowledge of EU MDR, MDSAP, and other relevant regulatory frameworks.
Strong analytical skills with the ability to interpret complex regulatory requirements.
Excellent communication skills in English; proficiency in Polish is advantageous.
Willingness to travel domestically and internationally as required.
What We Offer:
Opportunity to work with a team of dedicated professionals in a dynamic and supportive environment.
Continuous professional development and training opportunities.
Competitive salary and benefits package.
Flexible working arrangements, including remote work options.
The chance to make a meaningful impact on the safety and quality of medical devices worldwide
Application Process:
If you are passionate about quality and compliance in the medical device industry and meet the qualifications outlined above, we invite you to apply for this exciting opportunity.