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Quality Engineer
Devens
, MA Contract
On-Site
Quality Engineer
Devens, MA
1st Shift: 8:30 AM - 4:30 PM
12-Month W2 Contract
Quality Engineer Overview:
We are is seeking a detail-oriented Quality Engineer to support quality assurance initiatives across our operations. You’ll use your expertise in root cause analysis, quality engineering principles, and regulatory compliance to optimize processes, investigate issues, and ensure product and process excellence. This role offers hands-on experience in assembly and cleanroom environments, opportunities to work with cross-functional teams, and exposure to ERP systems.
Quality Engineer Key Responsibilities:
Quality Engineer Qualifications:
Devens, MA
1st Shift: 8:30 AM - 4:30 PM
12-Month W2 Contract
Quality Engineer Overview:
We are is seeking a detail-oriented Quality Engineer to support quality assurance initiatives across our operations. You’ll use your expertise in root cause analysis, quality engineering principles, and regulatory compliance to optimize processes, investigate issues, and ensure product and process excellence. This role offers hands-on experience in assembly and cleanroom environments, opportunities to work with cross-functional teams, and exposure to ERP systems.
Quality Engineer Key Responsibilities:
- Conduct root cause analysis and lead investigations to identify corrective and preventive actions.
- Support customer, regulatory, and internal audits.
- Maintain and lead validations, calibration programs, and environmental monitoring.
- Conduct internal and supplier audits to ensure ISO 9001 and FDA compliance.
- Collect and analyze data for metrics, trend reports, quality system reviews, and complaint resolution.
- Collaborate with cross-functional teams and manage external customer complaints.
- Update SOPs, Quality Management System documentation, and approved supplier index.
- Use ERP systems to track and report quality metrics and support continuous improvement initiatives.
Quality Engineer Qualifications:
- Education: Bachelor’s degree in Engineering or a related field.
- Experience: Minimum 3+ years as a Quality Engineer or similar role.
- Strong experience in root cause analysis and quality investigations.
- Hands-on experience in assembly or cleanroom environments preferred.
- Knowledge of ISO 9001 and other regulatory requirements.
- Experience with ERP systems preferred.
- Certification in Quality Engineering (CQE/CQA) or Lean Six Sigma preferred.
- Proven ability to collaborate with cross-functional teams and manage external customer complaints.
- Excellent written and oral communication skills, strong organizational ability, and attention to detail.
- Proficient in MS Office (Word, Excel, Access).
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