Quality Engineer I
Astrix IncHarvard, MA, United States8 hours ago
Job type
- Full-time
Job descriptionCalibration Program Environmental Monitoring Program Conduct internal and supplier audits to ensure compliance with ISO and FDA Quality System Regulation (QSR) standards. Collect, review, and interpret data for trend reports, metrics, quality system reviews, and complaint handling. Maintain and update the Approved Supplier Index as required. Review and approve quality assurance procedures, reports, and SOPs. Support the ongoing maintenance of the Quality Management System (QMS) under the direction of the QA Manager. Perform other duties as assigned. Bachelors degree in a natural or life science discipline (e.g., Chemistry, Biology, Microbiology, Cell Culture) or an equivalent combination of education, certification, and experience. CQE (Certified Quality Engineer) or CQA (Certified Quality Auditor) certification preferred. 35 years of relevant experience in a quality, regulatory, or laboratory environment. Strong knowledge of ISO and FDA Quality System Regulations (QSR). Proficiency in MS Office applications (Word, Excel, Access). Demonstrated experience in deviation and complaint investigations, including use of root cause analysis tools and technical writing. Detail-oriented with strong organizational, time management, and multitasking abilities.
Overview
Our Client, a Fortune 500 leader, is hiring for a Quality Engineer I. Be a part of a team setting science in motion across the biopharma, healthcare and advanced technologies industries. Are you ready to make a global impact? Join us now!
Job Title : Quality Engineer I
Location : Devens, MA
Contract duration : 1 year (possibility of extension)
Schedule : 1st shift - 8 : 30am - 4 : 30pm
Pay rate : $40 / hr
Responsibilities
- Apply Quality Engineering principles, tools, and techniques to develop and optimize systems and processes aligned with company strategy and regulatory requirements.
- Provide support for customer, regulatory, and internal audits.
- Utilize root cause analysis and risk assessment tools to conduct investigations and determine appropriate corrective and preventive actions (CAPA).
- Lead, coordinate, and maintain :
Validations across all departments
Qualifications
Note : This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
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Quality Engineer • Harvard, MA, United States
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