Job Description

NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976.

We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry’s premier provider. We provide support for clients during every step of the product development lifecycle and beyond.

Come and work for an organization with the:

Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the

Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core

Values:

• Act with integrity in everything we do.
• Provide best-in-class customer experiences.
• Develop superior talent and deliver expertise.
• Respond with agility and provide timely results.
• Embrace collaboration, diverse perspectives and ideas.

Job Description:

• Independently perform routine test article/product preparation and execute routine testing and perform routine calculations per NAMSA SOPs, and according to applicable work instructions. May be requested to conduct more involved studies.
• Participate in analyzing and interpreting results. Assure proper records and sufficient data are maintained on all testing and the research information is presented in a logical methodical comprehensive conclusive and scientifically sound manner.
• Perform laboratory testing utilizing knowledge of applicable standards or guidelines (may include: USP, AAMI, ISO and/or other required standards).
• Communicate test schedule updates to management as needed.
• Participate in the improvement of documents, test systems, quality systems and workflow.
• Procure and maintain all test equipment and supplies used for laboratory testing.
• Prepare or participate in the preparation of test specifications in conjunction with the requirements of the applicable standards and/or client instructions.
• Direct client contact as needed.
• Responsible for review of incoming test articles and paperwork for appropriateness and accuracy and for taking all concerns to management as required.
• Accurately collects and records raw data in logbooks and on worksheets.
• Maintain relevant supplies, materials, and equipment used in routine testing.
• Assure testing/test article preparation/product is performed within due dates.
• Prepare and maintain cell lines and reagents and/or test articles as required and applicable for testing.
• Routes all positive results or unusual testing occurrences to management.
• Responsible for checking laboratory equipment, being on-call and respond to continuous monitoring alarms as applicable. If needed, the Associate will respond in accordance with criteria outlined in Standard Operating Procedures.
• Perform required specific testing as applicable.
• Operate specified laboratory equipment as applicable.
• May perform Environmental Monitoring, clean and disinfect cleanroom suites (required as applicable).
• Other duties as assigned.

Qualifications & Technical Competencies:

• High school diploma or equivalent required and at least 4 years of experience or Bachelor degree and at least 2 years of experience.
• Sound judgment with effective decision making skills and the ability to solve problems or escalate as needed
• Awareness of applicable guidelines and regulations including, but not limited to USP, ISO, CTFA, FSA.
• Knowledge of metric system, NAMSA GLP and/or GMP testing, scientific applications, experimental design, and data evaluation.
• Ability to work in GLP/GMP environment.

Working Conditions:

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Requires maintaining physical condition necessary for walking, standing, or sitting for prolonged periods of time.
• Extensive use of computer keyboard; operate computer equipment.

NAMSA is an equal employment opportunity company.

NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws.