Medical Device Quality Assurance Auditor
3 weeks ago
About Intertek
Intertek is a global leader in quality assurance and testing, dedicated to exceeding customer expectations and fostering a culture of total quality assurance. We strive to make the world a better, safer, and more sustainable place for everyone.
Role: Medical Device Quality Assurance Auditor
As a Medical Device Quality Assurance Auditor, you will play a vital role in evaluating client management systems within the medical device industry. Your responsibilities will encompass conducting comprehensive audits to ensure compliance with industry standards and regulatory requirements.
Responsibilities:
- Conduct meticulous audits of client management systems, verifying adherence to ISO standards and relevant regulatory guidelines.
- Provide expert guidance and support to clients regarding audit processes and certification procedures.
- Prepare detailed audit reports, effectively communicating findings and recommendations to assessment team members.
- Contribute technical expertise to the medical device team, actively participating in continuous improvement initiatives.
Requirements:
- A bachelor's degree in a relevant field or equivalent professional experience.
- Minimum of four years of proven experience within the medical device industry.
- Exceptional communication and interpersonal skills, enabling clear and concise interactions with clients and colleagues.
- Ability to travel extensively, both domestically and internationally, as required by client needs.
Preferred Qualifications:
- Experience in auditing management systems, demonstrating a thorough understanding of audit methodologies.
- In-depth knowledge of regulatory requirements for medical devices across various countries.
- Training and certification in ISO standards and quality management systems.
- Broad experience with a diverse range of medical devices.
Physical Requirements:
- Ability to ascend/descend ladders, maintain prolonged standing, and lift/carry objects as needed.
- Strong communication and visual acuity skills are essential for effective performance.
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