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Job Requirements of Quality Engineer - CAPA:
-
Employment Type:
Contractor
-
Location:
Cambridge, MA (Onsite)
Do you meet the requirements for this job?
Quality Engineer - CAPA
Careers Integrated Resources Inc
Cambridge, MA (Onsite)
Contractor
Job Title: Quality Engineer - CAPA
Location: Cambridge, MA(Onsite)
Duration: 12 Months+ (Possibility of Extension)
Pay Range: $45 - $50/hr. on W2
Job Responsibilities:
Minimum required Education:
Preferred Certification:
Preferred Skills:
Location: Cambridge, MA(Onsite)
Duration: 12 Months+ (Possibility of Extension)
Pay Range: $45 - $50/hr. on W2
Job Responsibilities:
- Creates and executes comprehensive process validation strategies using statistical tools to ensure seamless transition of new products to production, meeting quality and regulatory standards, under limited supervision.
- Manages the entire design control process, from eliciting and validating design inputs to overseeing verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards.
- Drafts and updates detailed quality engineering documents, including quality plans for hardware, software, and systems, ensuring accuracy, compliance, and up-to-date records.
- Drives success of quality improvement projects by integrating quality, reliability, and Post Market Surveillance (PMS) insights into all product lifecycle stages.
- Conducts assessments of product and system designs, reviews performance data, and performs root cause analysis to identify and resolve quality deficiencies.
- Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety to ensure compliance with quality and regulatory requirements.
- Leads comprehensive risk management activities throughout the product lifecycle, identifying, assessing, and mitigating potential risks to uphold product safety and quality.
- Leverages post-market performance data to assess product effectiveness, providing feedback to manufacturing and design teams and initiating corrective actions when required.
- Prepares for quality audits and inspections, maintaining documentation and processes to demonstrate compliance with internal and external standards.
- Records, manages, and executes CAPA processes, including problem identification, root cause analysis, and implementation of preventive solutions for continuous improvement.
- Applies continuous improvement techniques to enhance quality practices, ensuring audit readiness and adherence to quality standards across the product lifecycle.
- Builds strong relationships with internal and external stakeholders, offering guidance and mentorship to maintain alignment with quality standards and project goals.
Minimum required Education:
- Bachelor's / master’s degree in mechanical engineering, Electronics Engineering, Science or equivalent. Minimum required Experience: Minimum 2 years of experience with Bachelor's in areas such as Quality Engineering, Safety Engineering, R&D Engineering or equivalent OR no prior experience required with master’s degree.
Preferred Certification:
- Six Sigma Green Belt
Preferred Skills:
- Design Quality Management
- Data Analysis & Interpretation
- Design for Quality (DFQ)
- Root Cause Analysis (RCA)
- CAPA Methodologies
- Regulatory Requirements
- Privacy, Safety, and Security
- Risk Assessment
- Technical Documentation
- Continuous Improvement
- Product Quality and Reliability
- Defect Management
- Design Verification Planning
- Design Validation Planning
- Product Test Design
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