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Compliance Auditor III

Rancho California, CA 92591

Posted: 06/06/2024 Employment Type: Contract Job Category: Quality and Compliance Job Number: 608162 Is job remote?: No Country: United States

Job Description


Must have a technical background, be familiar with applicable US and foreign regulations, standards, corporate and divisional standards. Specifically, the individual must have a working knowledge of Quality Systems Regulations (QSR) and International Standards (ISO13485). Additionally, the individual must understand a variety of quality/operational systems that support facility, product design, development, production, distribution, installation, and understand the principals of quality management.
Bachelor degree (in Engineering preferred) or equivalent experience and sufficient exposure to pharmaceutical or medical device related industries required along with 4+ years relevant experience as Internal Auditor, Quality Engineer and/or Manufacturing Engineer in an R & D and /or manufacturing environment in pharmaceutical or medical device related industries. Position requires significant product and systems related knowledge. Must have excellent oral and written communication skills.

Main Responsibility

•    Perform quality system and manufacturing process audits
•    Prepare audit report that establishes the outcome of the audit and the detail of non-conformances identified during the audits
•    Track audit results including corrective actions, and follow up to these actions as required
•    Support Abbott Third party and regulatory agency inspection as required
•    Provide support to SQA team as needed


Experience/Background:

•    Related work experience with a strong understanding of audit process per ISO 13485 and FDA regulations for Medical Device
•    A minimum of 6 years working in Medical Device Industry
•    Good problem-solving skills and critical thinking
•    Demonstrate excellent interpersonal skills when dealing with internal and external customers
•    Demonstrate fact-based decision-making skill.
•    Communicate effectively both written and oral modes
•    Ability to work independently and effectively with other team members
 

Education/Certification:  

•    Bachelor Degree – prefer in Science or Engineering
•    CQA (preferred)

 

Pay Rate Range: $25-36/hr. Salary will be commensurate with experience. This position is Non-Exempt. Hours over 40 will be paid at Time and a Half.
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About Rancho California, CA

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