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Compliance Auditor
2 months ago
Contract Duration 12+ months
Pay rate up to $39.56/hr
Main Responsibility:
Perform quality system and manufacturing process audits
Prepare an audit report that establishes the outcome of the audit and the details of non-conformances identified during the audits
Track audit results including corrective actions, and follow up to these actions as required
Support Client Third-party and regulatory agency inspection as required
Provide support to the SQA team as needed
Experience/Background:
Related work experience with a strong understanding of audit process per ISO 13485 and FDA regulations for Medical Devices
A minimum of 6 years working in the 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 skills.
Communicate effectively in both written and oral modes
Ability to work independently and effectively with other team members
Education/Certification:
Bachelor's Degree – prefer in Science or Engineering
CQA (preferred)
Job Description:
Must have a technical background, and be familiar with applicable US and foreign regulations, standards, and 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, and installation, and understand the principles of quality management.
Bachelor's 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 an Internal Auditor, Quality Engineer and/or Manufacturing Engineer in an R & D and /or manufacturing environment in pharmaceutical or medical device related industries.
The Compliance Auditor position requires significant product and systems-related knowledge. Must have excellent oral and written communication skills.
Notes:
This position is Non-Exempt.
Hours over 40 will be paid at Time and a Half.
Benefits:
Medical, Vision, and Dental Insurance Plans
401k Retirement Fund
About The Company:
Our client is a globally diversified healthcare company with a central purpose of helping people live their healthiest possible lives. They offer a broad portfolio of market-leading products that align with favorable long-term healthcare trends in both developed and developing markets. Working with this company, you'll tackle a wide array of problems including some of the world's greatest healthcare challenges while experiencing myriad cultures, geographies, and technologies. They are creating the future of healthcare through life-changing technologies and products that make you healthier and stronger, quickly identify when you have a medical need, and treat conditions to help you get back to doing what you love. It serves people in more than 160 countries with leading medical devices, diagnostics, nutrition products, and branded generic medicines.
If you are looking for a great company to work for, look no further because our client has received an average of a four-star rating from its thousands of employees that have written positive reviews on Glassdoor and Indeed.
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