Medical Device Auditor (Full-Time) (Home-Based ANY LOCATION USA)
Assurance – Delivery
Position: Medical Device Lead Auditor (Full-Time) (Home-Based USA)
Department: Medical Device
Location: Full-time Home Based- USA
Reports To:Operations Manager
Compensation: Competitive / Market, Base + Performance Bonus
Medical Device Lead Auditor
The Medical Device Lead Auditor leads a QMS audit or participates as a team member during certification of ISO 13485 – CMDCAS - 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 Devices
- 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
Qualifications 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 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.).
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 patients
o testing the devices concerned for compliance with the relevant national or international standards
o 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.
- 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.
At SAI Global, we help organizations proactively manage risk to achieve business excellence, growth, sustainability and ultimately, create trust.
Our integrated risk management solutions are a combination of world-class tech platforms, learning tools, and advisory services that operate across the entire lifecycle allowing businesses to focus on opportunities presented by uncertainty. Together, these tools and content services enable customers to develop a holistic, integrated view of risk.
SAI Global head office is located in Chicago. We employ more than 2,000 people across 29 countries and 51 locations across Europe, the Middle East, Africa, the Americas, Asia and the Pacific.