Senior Auditor at NAMSA in Irvine, California

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:

• \tMay conduct internal audits of NAMSA systems to assess compliance with applicable quality system regulations (i.e. ISO, GMP, GLP) and NAMSA SOPs.
• \tMonitor studies to assure management that facilities, equipment, personnel, methods, practices, records, and controls conform to the quality system regulations.
• \tAssure the quality and integrity of data through In-life inspections and final audit report.
• \tMay participate in audits of NAMSA suppliers and clients.
• \tReview protocols, reports and records for accuracy, consistency, and compliance.
• \tMay determine source of quality problems and make recommendations for improvements.
• \tMay establish follow up activities to assure corrective action is taken.
• \tMay assist in design of test validation programs and check sample evaluations.
• \tMay approve client submitted test specifications (GMP testing).
• \tMay coordinate changes throughout the change control process.

Qualifications & Technical Competencies:

• 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.
• 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.

Salary range: $75-80k annually

Working Conditions:

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

Pay Range Minimum:
$54,400.00

Pay Range Target:
$80,000.00

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.

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: