Intellectt Inc
Life Sciences & Pharma Recruiter @Intellectt Inc
Title:
Quality Engineer
Duration:
12 months
Key Responsibilities:
Ensure compliance with design controls, GMP, and regulatory requirements.
Develop and maintain quality procedures for inspection and release activities.
Perform first article and dimensional inspections; review engineering drawings.
Manage calibration systems and maintain quality documentation.
Collect and analyze quality data; prepare reports and support audits.
Coordinate with manufacturing partners and suppliers on quality issues.
Support laboratory testing and equipment qualification.
Qualifications:
8+ years of inspection or quality experience (medical device or regulated industry).
Knowledge of ISO 9000, FDA QSR, and GMP standards.
Skilled in MS Excel, Word, and basic statistical analysis.
Strong math and analytical skills.
Certifications like CMI or CQT are preferred.
High school diploma or higher in a relevant field.
Light lifting (up to 20 lbs) and standing for up to 4 hours required.
Occasional travel (~5%) for audits or project support.
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Quality Engineer
Duration:
12 months
Key Responsibilities:
Ensure compliance with design controls, GMP, and regulatory requirements.
Develop and maintain quality procedures for inspection and release activities.
Perform first article and dimensional inspections; review engineering drawings.
Manage calibration systems and maintain quality documentation.
Collect and analyze quality data; prepare reports and support audits.
Coordinate with manufacturing partners and suppliers on quality issues.
Support laboratory testing and equipment qualification.
Qualifications:
8+ years of inspection or quality experience (medical device or regulated industry).
Knowledge of ISO 9000, FDA QSR, and GMP standards.
Skilled in MS Excel, Word, and basic statistical analysis.
Strong math and analytical skills.
Certifications like CMI or CQT are preferred.
High school diploma or higher in a relevant field.
Light lifting (up to 20 lbs) and standing for up to 4 hours required.
Occasional travel (~5%) for audits or project support.
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