Medical Device Auditor (Contract) (Home-Based ANY LOCATION USA)
Company: SAI Global
Posted on: August 15, 2019
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
- 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
- Prepare audit report.
- Review audit results and communicate with the team
- Assess corrective action requirements resulting from
- Travel North America and internationallyQualifications and
- 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,
- 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
- 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
- Excellent interpersonal, written and verbal communication
- 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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