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Compliance Auditor job in Temecula, CA

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Temecula, CA CorTech LLC

Job Ref:  358444
Employer:  CorTech LLC
Job Type:  Contract
Salary and Benefits:  39.84/Per Hour
Remote:  No

Location

City:  Temecula, CA
Post Code:  92591
Map: 

Description

JobsRUs.com. is seeking to hire a Compliance Auditor for our client in Temecula, CA!
Benefits Available!
Weekly Pay!
$39.84/Hour

Shift:8am-5pm

Description:

This position is Non-Exempt. Hours over 40 will be paid at Time and a Half. 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 client 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)
ref: (358444)
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