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Medical Device Auditor (Contract) (Home-Based ANY LOCATION USA)

Company: SAI Global
Location: Oakland
Posted on: August 15, 2019

Job Description:

Position: Medical Device Lead Auditor (Contractor) (Home-Based USA) Department: Medical DeviceLocation: Contract Home Based- USAReports To: Operations ManagerCompensation: Competitive / MarketWebsite: www.saiglobal.com Medical Device Lead Auditor The Medical Device Lead Auditor leads a QMS audit or participates as a team member during certification of ISO 13485 - MDSAP audits and in accordance with the company's accredited certification program. The Auditor is to interface with clients, technical support. This position reports the Technical Manager of Medical DevicesKey Responsibilities:

  • 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 internationallyQualifications and Experience:
    • 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; o closely related industries and the workplace such as research and development, regulatory affairs, manufacturing;o the application of medical device technology and its use in health care services and with patientso testing the devices concerned for compliance with the relevant national or international standardso conducting performance testing, evaluation studies or clinical trials of the devices.o Preferably, the candidate is already a qualified quality management system auditor within the medical device industry.
      • o Ideally, the candidate will have extensive technical knowledge associated with the Medical Device field (e.g., Sterilization, Biocompatibility, Electrical Medical Device Safety, etc.) as well as extensive regulatory expertise (e.g., worldwide quality and compliance regulations including Canadian, Europe, etc.).Education/Professional Qualifications:
        • 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.Interpersonal Skills:
          • 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 desirableFull commitment to conduct business with the utmost integrity and in full compliance with the law is absolutely essential. SAI Global is a recognized leading provider of integrated risk management solutions, assurance, and property services. We help organizations protect their brands by proactively managing risk to achieve business excellence, growth, sustainability, and trust. We have a history rich in the development of innovative business solutions, and today this tradition of innovation continues with industry-leading products and solutions in our core business areas of risk management software, standards aggregation, regulatory content, ethics and compliance learning, risk assessments, certification, testing and audits. SAI Global acquired BWise from Nasdaq in 2019. The combination of BWise's award-winning risk management, internal audit and regulatory compliance platform with SAI Global's industry leading SAI360 risk and compliance solution will create the most complete integrated approach to risk management in the marketplace.For more information, visit our company site at www.saiglobal.com or our career site.

Keywords: SAI Global, Oakland , Medical Device Auditor (Contract) (Home-Based ANY LOCATION USA), Accounting, Auditing , Oakland, California

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