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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:
Principal Duties and Responsibilities
• Conduct internal audits of NAMSA systems to assess compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
• Monitor studies to assure management that facilities, equipment, personnel, methods, practices, records, and controls conform to the quality system regulations.
• Assure the quality and integrity of data through In-life inspections and final audit report.
• Participate in audits of NAMSA suppliers and clients.
• Review protocols, reports and records for accuracy, consistency, and compliance.
• Determine source of quality problems and make recommendations for improvements.
• Establish follow up activities to assure corrective action is taken.
• Assist in design of test validation programs and check sample evaluations.
• Approve client submitted test specifications.
• Coordinate changes throughout the change control process.
Qualifications and Skills
• Requires a Bachelor’s degree in a scientific discipline.
• Requires 4-6 years related experience.
• Some Regulatory Interface experience.
• May require HCT/P (Human Tissue) experience.
• Fluency in English is preferred.
Technical Competencies
• Maintain personal and professional competency in Quality Assurance and the biomedical industry in general.
• Awareness of issues of control for scientific bias
• Knowledge of statistics and metric system
• Knowledge of use of biostatistics, statistical process control techniques, and test validation methods
• Knowledge of ISO/GLP regulations.
• Knowledge of GMP regulations required in the US.
• May require HCT/P regulations knowledge.
• Fundamentals of technical writing.
Working Conditions
• Physical activities include walking, sitting and standing for prolonged periods.
Pay Range
$75,000-$80,000
Pay Frequency:
Annual
Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills.
Full Time
Scientific Services
$95k-123k (estimate)
06/12/2024
07/10/2024
namsa.com
NORTHWOOD, OH
500 - 1,000
1967
Private
JOHN J GORSKI
$50M - $200M
Scientific Services
NAMSA is an Ohio-based contract research organization that provides product development, biological safety consulting and clinical research services for the medical industry.