Auditor

NAMSA Pioneering Medical Device Materials

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
• 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.

Compensation Target: $70,304.00

Job Description

• Evaluate data and/or lab work to assess compliance with quality system regulations (ISO, GLP, etc.) and SOPs.

• Review records for accuracy, consistency, and compliance.

• May participate in audits of NAMSA facilities, suppliers and agencies.

• Perform periodic audits/inspections of internal operations to assess internal performance and detect quality problems.

• May investigate source of quality problems and makes suggestions for improvements.

• May assure corrective action is taken through follow up activities.

Salary Pay Range: $70,304-71,000

Qualifications & Technical Competencies

• Requires a Bachelor's degree in a scientific discipline or an Associate's degree with at least 2 years of experience in a GLP testing laboratory.

• Requires 0-2 years auditing experience.

• Fluency in English is preferred.

• 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 GMP/GLP regulations, as appropriate

• Fundamentals of technical writing

Working Conditions:

• Physical activities include walking, sitting and standing for various periods.

• Physical requirements include being able to occasionally move or lift up to 25 pounds (12 kgs).

• Specific vision abilities include close vision, color vision, and ability to adjust focus.

• Employee must be able to talk and hear.

The compensation grade range for this position is: $45,500.00 - $88,500.00 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.

NAMSA is an equal employment opportunity company.

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

Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position:

• May operate equipment
• Records data timely and accurately
• May analyze and interpret data
• Conducts studies on medical devices that have an impact on human life

A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.