Quality Engineer
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Full Time
- Ingenieros Engineering / (Ingeniero de Calidad) (Quality Engineer)
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Anasco
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mas de 6 meses Desde $35.00 Hasta $35.00 hr more than 6 months From $35.00 To $35.00 hr -
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Qualifications & Requirements – Quality Engineer
We are seeking a driven, detail-oriented Quality Engineer to join our team. The ideal candidate is passionate about quality systems and thrives in a highly regulated environment. If you are eager to drive change, improve processes, and ensure world-class product quality, we want to hear from you!
Requisitos:
Requirements:
Key Requirements: Bachelor’s degree in Chemical, Biomedical, Mechanical, or Industrial Engineering required. 5 to 7+ years’ experience in an FDA-regulated environment. Prior experience working in ISO-classified cleanrooms. Experience with Quality System Regulation (QSR), ISO standards, Design Controls, and Process Validation. ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred. Medical device industry experience preferred but not required. Knowledge of lyophilization and qualifying facility expansions (HVAC, water filtration systems). Proven ability to develop technical documentation such as Validation Protocols, SOPs, Validation Plans, Technical/Investigation Reports, and Change Controls. Deep understanding of developing, documenting, and implementing quality systems to meet domestic and international standards. Basic understanding of audit processes including planning, executing, and reporting audits. Fully bilingual (English/Spanish) required.
Requiere Mucha Experiencia Requires Expert
Requisitos:
Requirements:
Key Requirements: Bachelor’s degree in Chemical, Biomedical, Mechanical, or Industrial Engineering required. 5 to 7+ years’ experience in an FDA-regulated environment. Prior experience working in ISO-classified cleanrooms. Experience with Quality System Regulation (QSR), ISO standards, Design Controls, and Process Validation. ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred. Medical device industry experience preferred but not required. Knowledge of lyophilization and qualifying facility expansions (HVAC, water filtration systems). Proven ability to develop technical documentation such as Validation Protocols, SOPs, Validation Plans, Technical/Investigation Reports, and Change Controls. Deep understanding of developing, documenting, and implementing quality systems to meet domestic and international standards. Basic understanding of audit processes including planning, executing, and reporting audits. Fully bilingual (English/Spanish) required.
Requiere Mucha Experiencia Requires Expert
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