Job Summary
- Company
- TUV SUD AMERICA INC.
- Location
- Peabody, MA 01960
- Industries
- Biotechnology/Pharmaceuticals
- Medical Devices and Supplies
- Job Type
- Full Time
- Employee
- Years of Experience
- 2+ to 5 Years
- Education Level
- Bachelor's Degree
- Career Level
- Experienced (Non-Manager)
- Salary
Competitive- Job Reference Code
- TUVS&R
Medical Device Expert
About the Job
TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has immediate openings at our offices in Peabody, MA, and New Brighton, MN for
Medical Device Auditors / Experts
Your role and responsibilities include assessment of medical devices and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management.
Responsibilities:
Auditing:
· Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD) and International quality system standards (e.g. ISO 13485) as well as internal Notified Body and TÜV SÜD America criteria including all related tasks, such as scheduling, planning, reviewing corrective actions, preparing reports and audit documentation for submission to the certification committee of the Notified Body.
Testing:
· Act as Test engineer and Technical Certifier for TÜV SÜD America; inspect and test products for conformity with international regulations, with the end result being the certificate of conformance for the client in accordance to CB, NRTL, and SCC.
· Prepare reports and documentation for certification of customer products to the appropriate standards. Perform Constructional Review, Testing, and Preliminary Evaluations activities.
File Reviewes:
· 510(k) FDA file reviews
· Design Dossier (EU Directives)
· Technical File Review (EU Directives)
Project Management:
· Provide project management for NAFTA-based customers. Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating audit team, and answering client questions.
Communication / Customer Service:
· Communicate in a courteous and effective manner with internal and external customers in all circumstances including answering questions, relaying messages, and providing information with regard to standards, regulatory and technical requirements for compliance with standards and the respective regulatory system.
Expertise:
· Keep abreast of present and pending regulatory requirements, standards and TÜV SÜD America service capabilities through internal training sessions, external seminars, and reading of scientific articles.
Requirements:
· The ideal candidate will have a BS or MS Degree in a science related field (biotechnology, biology, chemistry, microbiology, electrical engineering, mechanical engineering, etc.)
· Significant industrial medical device experience e.g. as Product Designer / Product Development Scientist / Project Manager / Microbiologist / Sterilization Specialist / Engineer / Regulatory Affairs / Quality Assurance.
· Minimum of 5 years experience in an industrial medical device environment, ideally 2 years of them in Quality.
· Direct auditing experience Medical Device Directives (AIMD, MDD, CMDCAS, JGMP, IVD) ISO 13485and Lead Auditor Certification is beneficial.
· Spanish language a plus.
· Extensive domestic travel and occasional international travel is required.
We offer excellent medical and dental health plans, and participation in the company 401(k) retirement savings plan. We will provide a path to become a ISO13485 Medical Device Lead Auditor, Notified Body Auditor, FDA 3rd party 510K reviewer.
Please send your resume and cover letter to TÜV SÜD America Inc, Human Resources at:
Email: careers@tuvam.com or Fax: (978)977 0248
All information will be treated with strict confidentiality.
Headquartered in Peabody, MA, TÜV SÜD America Inc., a $100 million subsidiary, provides management system certification services to ISO 9001, ISO 14001, AS9100, AS9120, ISO 13485, TL 9000, Safe Quality Food (SQF), ISO 22000 and more. TÜV is a leading EU Notified Body for the Medical Devices, Active Implantable Medical Devices and In Vitro Diagnostic Directives. Testing services include CE Marking assistance, Mechanical/Electrical Product Safety, Electromagnetic Compatibility (EMC), Environmental Testing, NRTL and SCC certification, Restricted Substance Services, International Compliance Services and more. Globally, TÜV has issued over 190,000 product and 30,000 quality management system certifications. For more information, visit www.TUVamerica . com. TÜV SÜD America offers a competitive compensation package that includes health insurance and participation in the company 401(k) retirement savings plan.
TÜV SÜD is one of the leading providers of approval services for medical devices. Represented at 44 locations in major economic centers, the medical Health and Services experts support over 1,000 customers in all issues related to the certification and testing of medical devices and in-vitro diagnostics for target markets in Europe, Asia, America and Australia. With a 30 percent market share, TÜV SÜD Product Service is the world’s leading provider of approval services for high-risk products.
Thank you for your interest in TÜV SÜD America! For direct contact you may email at careers@tuvam.com
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TUV SUD AMERICA INC.
