Are you looking to join an exciting new company!
SAI Global is looking for a Medical Device Auditor to lead a QMS audit or participate as a team member during certification of ISO 13485 – CMDCAS – MDSAP audits and in accordance with the company’s accredited certification program.
• Audit against QMS for compliance with ISO 13485, CMDCAS and MDSAP.
• Act as Lead Auditor or team member.
• Communicate with client regarding audit activity.
• Assess the client’s QMS documentation.
• Verify and document evidence of compliance and non-compliance.
• Prepare audit report.
• Review audit results and communicate with the team members.
• Assess corrective action requirements resulting from assessments.
• Travel North America and internationally
• Minimum of 4 years work experience in medical device and/or life sciences related industry including at least two years of work experience in quality management, external/internal auditing or relevant work experience in one or more of the following;
• Minimum 3 years’ experience in auditing Third party auditing industry management systems, specifically in ISO 13485.
• Bilingual English / French would be an asset.
• Computer and writing skills.
• Four (4) post-secondary education and degree from a university or technical college University degree in related field; Graduate degree would be preferred.
• Completed lead auditor training for ISO 13485 Lead Auditor training.
• Experience in auditing QMS in the medical device industry.
• Preference for a combination of education and experience in medicine, science or engineering.
• Certified auditor/trainer in any of the medical devices standards.
• Excellent interpersonal, written and verbal communication skills required;
• Strong and effective people management, with great communication and liaising skills
• Track record of business planning and future thinking is desirable
Full commitment to conduct business with the utmost integrity and in full compliance with the law is absolutely essential. SAI Global is an equal opportunity employer.
At SAI Global, we help organizations proactively manage risk to achieve business excellence, growth, sustainability and ultimately, create trust……Read more>>