US: Life Sciences Quality Assurance Engineer
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Life Sciences Quality Assurance Engineer
Develops and implements processes, procedures, forms, metrics and tools for quality systems.
Reviews and revises/approves quality and validation documents.
Experience in change control, non-conformance investigations, new material and batch release, quality systems auditing and validation review.
Conducts training for Life Sciences, Bioprocess and IVD teams in quality systems processes to ensure adherence
•Minimum 3 years, prefer 5 years in quality, validation or compliance role in an IVD industry •Requires intermediate skills in MS Office, SPC software, knowledge of ISO standards, and document control software •QA and QMS experience •Experience in development of GMP systems •Experience with FDA/regulatory audits desired. EMEA experience preferred. •Understanding of FDA 21 CFR, ISO9001 requirements and how it applies to crucial raw material vendors •Works on assignments requiring considerable judgment and initiative; understands implications of work and makes recommendations for solutions •Excellent verbal and communication skills •Project management experience/ organizational skills •Ability to work across departments, silos and global cultures
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