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:
• Perform routine test article preparation according to work instructions.
• Required to calculate surface areas of regular geometric shapes.
• Communicate test schedule updates to NAMSA management as needed.
• Assure test article preparation is performed within due dates.
• Prepare and maintain test articles as required for testing.
• Maintain ancillary records (logbooks, worksheets).
• Maintain relevant supplies and equipment used in preparations.
• May be responsible for chain of custody, delivery of samples, filing and sample distribution
• May order and/or stock supplies subject to approval.
• May be required to operate autoclave.
Qualifications & Technical Competencies:
Principal Duties and Responsibilities
- Performs routine test article preparation according to work instructions. May interact with clients during sample preparation or discussion of appropriate method for preparation.
- Performs routine and complex calculations and can route all issues or errors to Management.
- May provide on the job training.
- Assure test article preparation is performed within due dates.
- Maintain relevant supplies, materials, and equipment used in routine testing.
- Maintain ancillary records (logbooks, worksheets).
- Participate in the improvement of documents, test systems, quality systems, and workflow.
- May be responsible for checking laboratory equipment.
- Perform Environmental Monitoring clean/disinfect the hood
- Order and/or stock supplies subject to approval.
- May be responsible for chain of custody, delivery of samples, filing and sample distribution
- May be responsible for review of incoming test articles and paperwork for appropriateness and accuracy and taking all concerns to management as required.
- Required to operate autoclave.
Qualifications and Skills
- Bachelor’s degree, in a scientific or mathematic discipline preferred and at least one year of related laboratory experience, or a high school diploma with at least 3 years of relevant laboratory experience.
Technical Competencies
- Awareness of applicable guidelines and regulations appropriate for primary department, these may include USP, ISO, CTFA, FSA, ICH, EP, and/or JP.
- Knowledge of metric system, scientific applications, experimental design, and data evaluation.
- Can draft technical documents and communications (SOPs, protocols, Trackwise records).
- Proficient at applicable NAMSA systems (LIMS, Trackwise, MasterControl, etc.) as appropriate per primary department.
- Ability to work in GMP/GLP environment.
Working Conditions
- Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
- Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
- Physical requirements include frequently lifting up to 25 pounds or more on occasion.
- Employee must be able to talk and hear.
Working Conditions:
• Physical activities include standing, walking, sitting, using hands to finger, handle, or feel, and reaching with hands and arms. Occasionally required to climb or balance.
• Vision abilities required include close vision, color vision, depth perception, and ability to adjust focus.
• Physical requirements include frequently lifting up to 25 pounds or more on occasion.
• Employee must be able to talk and hear.