Quality Engineer
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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:
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.
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