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Quality Engineer II

1 month ago

Chelmsford, United States V R Della IT Services Private Limited Full time
*Urgent Need- Day Shift- $35/hr*
* *Position: Quality Engineer II*
* *Location: Chelmsford, MA 01824*
* *Duration: 12 months temp (may get extended)*
* *Pay Rate: $35/hr *
* *Shift 8am-5pm M-F*

Job Summary:
As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility acting as a Quality Engineering subject matter expert. You will make an impact by conducting root cause analysis (RCAs) and implementing corrective/preventative (CAPAs) actions to reach effective problem resolutions. You will also provide quality leadership to improve Critical to Quality (CTQ) parameters to support overall site improvement efforts.
Essential Functions:
• Investigate process/product deviations and out of specification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams, 5-Whys…etc.
• Ensure DEA compliance and act as a CSP coordinator
• Handle customer complaints with professionalism and efficacy.
• Troubeshoot electrodes and buffer solutions.
• Implement corrective and preventative actions (CAPAs) to prevent recurrence of deviations and nonconformances. Verify effectiveness of implemented changes utilizing the proper quality tools.
• Provide guidance for the disposition of non-conforming material (final product and raw material).
• Perform statistical analysis to monitor process and product performance and react to negative trends.
• Lead change controls for complex improvement projects utilizing risk-based methodologies.
• Have an expert level knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma and control plans.
• Lead and participate in generating risk assessments (product and process- FMEAs).
• Have strong knowledge of process, product and equipment validation principles (i.e IQ/OQ/PQ..etc). This includes generating protocols and reports, creating acceptance criteria, establishing proper sampling plans and completing statistical analysis.
• Maintain the site’s Quality Systems’ conformance to ISO standards and regulatory requirements and policies.
• Drives for continuous improvements in all areas and support improvements efforts, implement changes, and verifies effectiveness of changes.
• Support internal and external audits, customer audits, supplier audits.
• Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
• Write or revise standard quality control operating procedure and quality system documentation as required.
• Write technical reports such investigation summary reports and change management records.

Job Types: Full-time, Contract

Pay: $35.00 per hour

Expected hours: 40.00 per week

Benefits:
* Health insurance
Schedule:
* 8 hour shift
* Day shift
* Monday to Friday

Work Location: On the road