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In office (San Juan)
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Principal
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Regulatory compliance, validation, quality systems & technology consulting for pharma, medical device & biotech. Founded 2005 in Puerto Rico.
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.
Log on now to our website http://www.qrcgroup.com / to learn more about our services and solutions!
We are seeking a Process Engineer with pharma-medical device experience as well as validations life-cycle experience (write/execute/analyze/close) to support the daily operations:
- Root cause analysis
- Investigation experience for QN/CAPAclosures
- Experience with manual and automated systems/lines
- Bachelor's Degree in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related field).
- Strong experience in the Medical Device industry (required).
- Pharmaceutical industry experience (preferred).
- Demonstrated experience with validation life cycle activities (design, execute, analyze, and close protocols/reports).
- Experience performing root cause analysis and implementing solutions.
- Experience supporting investigations, QN, and CAPA closures.
- Experience working with manual and automated manufacturing systems/production lines.
- Ability to work effectively in a fast-paced manufacturing environment.
- Standard site schedule; flexible to support 24/7 operation including shifts, weekends, and holidays as operational demands requireBilingual (English and Spanish) required.
- Availability to work in Texas.
All your information will be kept confidential according to EEO guidelines.
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