SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries, and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.
Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.
Organizations today are met with a variety of operational and business challenges. External forces, like competitors and regulatory bodies, also add a secondary level of pressures that must be anticipated. At SGS, our Certification and Business Enhancement (CBE) group has developed a variety of solutions to not only meet these challenges, but establish more efficient and profitable ways of working.
The successful candidate will perform third-party audits and technical information review in accordance with SGSs Certification procedures and the requirements of ISO 9001, ISO 13485, MDSAP, MDD, IVDD, and/or JPAL.
**We are seeking candidates to serve our clients on the West Coast and Midwest**
Make relevant decisions concerning the audit process and for informing SGS to resolve issues outside the audit process.
Collect and analyze sufficient information to provide a recommendation for certification, with authority over the control and performance of auditing activities.
Lead a team of auditors in performing medical device audits, in conformance with the SGS Global/Local procedures.
Access and review North American clients medical devices quality systems and technical information to the requirements of ISO 9001, ISO 13485 and other regulatory requirements for access into Canada, European Union (EU), Japan, and review technical dossiers to the requirements of 93/42/EEC (MDD) and/or 98/79/EC (IVDD).
Determine (upon evidence gained during audits) whether or not manufacturers are in compliance with all relevant standards/regulations, and whether registration should be recommended or allowed to continue.
Present SSC Standard Training Courses and, upon approval, deliver such courses in a tutoring role.
Provide technical advice to marketing and sales functions, as required. Utilize and maintain professional communication and presentation skills while meeting with clients.
Respond to client inquiries on all technical matters regarding SGS-SSC certification/training products.
Report customer complaints, problems and/or system deficiencies to the Director of Healthcare and Certification Management.
Assist in the training of other auditors and lead auditors during planned audits or during other training functions.
Participate actively in witness audits by SGS or accreditation bodies.
Education and Required Skills:
Bachelors degree in Engineering or a related field plus 3 years of experience in the job offered or related occupation preferred.
4 years of experience with engineering and technical applications used in the development of medical devices.
4 years of recent and relevant medical industrial or business experience within the medical device manufacturing industry and/or medical device certification industry; solid understanding of Global Regulatory Affairs, including the European Medical Device Directive (MDD); and competent working knowledge of nationally recognized Quality Management System auditing standards and procedures.
May work from home anywhere in the Midwest or West coast.
Additional Information: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the companys rights to assign or reassign duties and responsibilities to this job at any time.
SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.