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
- Calibration 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.
Qualifications
- Bachelor’s 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.
- 3–5 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.
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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