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 a
Sterilization and Microbiology Auditor / Expert
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 (e.g.catheters, heart valves, stents, disposables, etc.) and their manufacturers with a special focus on environment control and sterilization processes 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 & Responsibilities
- The ideal candidate will have a BS or MS Degree in a science related field (biology, chemistry, microbiology, etc.)
- Significant industrial medical device experience e.g. as Chemist / Biologist / Microbiologist / Sterilization Specialist / Biochemist
/ Pharmacist / Biomedical Engineer
- Minimum of 5 years experience in an industrial medical device environment with primary responsibility on the area of environment control and sterilization, ideally 2 years of them in Quality.
- Minimum 2 years of professional experience on the area of the respective sterilization method, practical experience of sterilization validation;
- Direct auditing experience Medical Device Directives (AIMD, MDD, CMDCAS, JGMP, IVD) ISO 13485and Lead Auditor Certification is beneficial.
- Spanish language a plus.
- Regular domestic travel and international travel is required.
Why should you join TÜV SÜD America?
- Competitive compensation package that includes health & dental insurance
- 401(k) retirement savings plan with matching contributions
- Paid Time off for volunteering in the community
- Wellness Programs:
- Fitness and Weight Loss Reimbursement through our Health Plan
- Additional rewards for leading a healthy lifestyle
- Flu Clinics
- Health & Wellness Education
- Walking Clubs
- Employee Assistance Program - a program of services that provides assistance to employees and families with balancing the demands of work and home.
- Corporate sponsored running and walking events
- Company sponsored outings and holiday events
- Softball and Bocce Tournaments
- Opportunities to expand your career internationally and work alongside people from diverse cultures and backgrounds
- Develop and grow in a performance-based environment that recognizes and rewards top performers
- Continuous training and learning opportunities to support the professional and personal development of our employees
- Work alongside experts and market leaders in a company with a strong recognizable brand worldwide
- Make a positive contribution to change and progress; doing your part to ensure safety, quality and environmental sustainability
We look forward to hearing from you! Click on Apply Now button for quick and easy aplication process guidelines.
Or, if you prefer, please email your resume and cover letter, clearly stating the position you are applying for, to:
firstname.lastname@example.org or Fax: (978) 977-0248
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, veteranstatus and those laws, directives, and regulations of Federal, State, and Local governing bodies or agencies.