TÜV SÜD America Inc., a global leader in product safety and EMC testing, regulatory affairs and certification, has an immediate opening at our offices in the USA for an Expert Auditor - Cardiac Products
At TÜV SÜD America, we are passionate about technology, people and the environment. For almost 150 years, our employee’s contributions and enthusiasm have been essential to the success of our business. Our commitment is to invest in our employees as well as to hire, develop, and engage the best talent to help us continue to build our team. We are dedicated to creating a work environment where all levels of employees are inspired to learn, grow, and be empowered to achieve both their professional as well as personal goals.
We are looking for personable and outgoing individual who will work closely with our medical device customers. This position will be the key contact to proactively provide superior customer service to customers. Your role and responsibilities include assessment of non-active medical devices – with special focus on cardiac implants - and their manufacturers per the European Medical Devices Directives, other applicable Regulatory Systems and International standards, including related client and project management. We are looking for a detail oriented individual with conformity testing experience, ideally within the medical / regulatory field and who wants to add value to our organization.
Roles and Responsibilities:
Perform regulatory audits of clients per European Medical Device Directives (AIMD, MDD, IVDD), Canadian Medical Device Regulations (CMDR), Japanese Pharmaceutical Affairs Law (JPAL) 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.
Perform evaluations of regulatory submissions including: Design Dossier (EU Directives), Technical File Review (EU Directives)
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.
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.
The ideal candidate will have a BA or MS Degree in a science related field (biomedical or mechanical engineering, chemistry, biotechnology, biology, etc.)
- Minimum of 5 years experience in an industrial medical device environment on the area of Product Designer / Product Development / Manufacturing Engineer of cardiac products;
- Minimum 2 years of quality management related activities;
- Hands on experience with cardiac products such as catheters, guidewires and cardiac implants;
- Familiarity with aseptic manufacturing technologies, packaging is a plus;
- Openness for relocation to Minneapolis, MN is a plus;
- Regular domestic travel and international travel is required.
We look forward to hearing from you. Please send your resume and cover letter to TÜV SÜD America Inc, Human Resources at: firstname.lastname@example.org or Fax: (978)977 0248
TÜV SÜD America offers a comprehensive compensation package that includes health insurance and participation in the company 401(k) retirement savings plan.
TÜV SÜD America, Inc. is an equal opportunity, affirmative action employer and considers qualified applicants for employment without regard to race, color, creed, religion, ancestry, marital status, genetics, national origin, sex, sexual orientation, gender identity and expression, age, physical or mental disability, veteran status and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies. We participate in the E-Verify Employment Verification Program.