Extraction Specialist

With a legacy spanning over 150 years, TÜV SÜD is a global leader in technical services, employing more than 25,000 professionals across 1,000 offices worldwide. For over 30 years, TÜV SÜD America has been dedicated to advancing safety, sustainability, and innovation across 33 locations. Committed to protecting people, property, and the environment from technology-related risks, we drive consumer protection, digital transformation, and sustainable development.

TÜV SÜD’s Medical Device Testing Lab specializes in medical device and packaging testing, offering a comprehensive, one-stop solution for manufacturers. Our lab consists of four specialized disciplines—Biocompatibility, Chemistry, Microbiology, and Packaging—ensuring excellence in medical device evaluation.

Position Summary:
We are seeking an Extraction Specialist to join our Medical Device Testing Lab, focusing on Chemical Characterization extractions of medical devices. This role involves performing extractions and analyses in a dynamic, fast-paced environment in accordance with ISO 10993, ISO/IEC 17025, GLP/GMP, and other relevant standards. The ideal candidate will have experience in sample preparation and extraction, with expertise in extractable and leachable testing considered a strong advantage. Additionally, strong client service, project management, quality system knowledge, and collaboration skills are essential for success in this role.

Responsibilities:

- Routinely perform sample extraction of various medical devices for analytical evaluation in accordance to ISO 10993 or other required guidance.

- Perform Non-volatile residue (NVR), TOC, FTIR, UV-VIS experiments in support of chemical characterization studies

- Assist with other instrumentation techniques (LCMS, GCMS, ICP) as needed

- Perform method development and method validation as directed

- Operate and maintain various lab equipment including incubators, ovens, FTIR, UV-VIS, etc.

- Assist with execution of equipment installation, qualifications, and validations

- Assist in the development of the laboratory quality, compliance, and laboratory support systems including SOP writing

- Collaborate and clearly communicate with cross-functional teams and clients to ensure client's needs are met

- Contribute to continual lab improvements including new method development and improvement of existing methods

- Minimum BS/BA in chemistry or related field with at least 2 years of relevant experience.

- Knowledge and previous experience performing sample extract preparation in the areas of extractables/leachable is preferred.

- Additional experience with FTIR, UV-VIS, IC as a bonus

- Previous experience with method development and method validation for analytical techniques

- Strong working knowledge of industry regulations (ISO 10993 series of standards, ISO 17025, ISO 13485, and GLPs)

- Ability to organize and track multiple projects in a detail-oriented

- Ability to work and be effective with minimal supervision

- Ability to prioritize and execute on daily project tasks

- Strong organizational skills 

- Excellent written and oral communication skills and be a proactive, collaborative team player

- Self-starter with a positive and motivated attitude

Equal Opportunity Employer – Disability and Veteran

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.

For more information on applicable equal employment regulations, please refer to the following: Labor Law 2025

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