Medical Devices Quality Assurance Specialist
4 days ago
This position performs third-party audits in Canada and the US, ensuring compliance with SGS Certification procedures and regulatory requirements. The successful candidate will have experience in quality assurance, auditing, and technical information review.
- Lead Auditors have authority for the control and performance of auditing activities, including planning and team management.
- The role involves leading a team of auditors in performing medical device audits, conforming to SGS Global/Local procedures.
- The incumbent is responsible for collecting and analyzing sufficient information to provide a certification recommendation.
- The position requires reviewing North American clients' medical devices quality systems and technical information against regulatory requirements.
- The successful candidate must decide whether manufacturers are in compliance with relevant standards and regulations.
- Providing technical advice to marketing and sales functions, as required.
- Bachelor's Degree in Science or Engineering, or equivalent.
- 10 years' experience in Medical Devices Manufacturing/Industry, with 3 years minimum in quality or regulatory related functions.
- Minimum 5 years of experience auditing for ISO 13485, MDSAP, MDD, IVD, IVDR, UKCA, and MDR standards.
- Satisfactory completion of an RAB/QSA or IRCA approved training course in Quality auditing.
- Registered (IRCA and/or RAB/QSA) Quality Lead Auditor.
- Strong background in either design engineering or research and development.
- Global Regulatory Affairs background, including MDD / IVDD.
- FDA 510(k) experience.
- Experience in radiation, neurological, soft tissue implant, absorbable products, orthopedic, active therapeutic/diagnostic supplying energy, active administration, animal tissue, and/or combination product devices.
- Broad knowledge of nationally recognized Quality Management System auditing standards and procedures.
- Ability to travel (80% -100%) to the US, including a valid driver's license.
- Extended hours and shift work may be required from time to time.
We offer a competitive salary range of $120,000 - $180,000 per annum, depending on location and experience.
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