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Compliance Auditor III

Rancho California, CA 92591

Posted: 07/09/2024 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.

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About Rancho California, CA

Ready to take the next step in your career? Discover exciting job opportunities in the vibrant area surrounding Rancho California, California! Known for its stunning vineyards, charming Old Town, and close proximity to beautiful destinations like Temecula Valley, this region is a hub of opportunity and growth. With a dynamic job market, cultural attractions like the Temecula Valley Wine Country, Pechanga Resort Casino, and the Old Town Temecula Community Theater, not to mention a thriving food scene and outdoor recreational activities at the Santa Rosa Plateau Ecological Reserve, Rancho California offers an enchanting backdrop for professional success. Explore our listings today and let your career flourish in this unique and inviting locale.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.