Quality Engineer

1 month ago

Chelmsford, United States Integration International Inc. Full time

Job Description:

  • 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-Why etc.
  • Ensure DEA compliance and act as a CSP coordinator
  • Handle customer complaints with professionalism and efficacy.
  • Troubleshoot 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 supports 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.


Requirements – Knowledge - Skills:

  • Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline. A graduate degree (MS) is also a plus.
  • A minimum of 6 years prior experience in a Quality Engineering role preferably in a cGMP Biotech or Life Science site.
  • Proven experience with titrators and PH testing
  • Strong verbal and written communications skills in English.
  • Ability in technical and statistical writing.
  • Must have experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
  • Ability to work in a matrix organization.
  • A fundamental understanding of a quality system and its development, documentation, and implementation with respect to domestic and international standards or requirements.
  • Understanding of the audit process including types of audits, planning, preparation, execution, reporting results, and follow-up.
  • Strong analytical, problem resolution, judgment, and decision-making skills
  • Operation requires the use of safety equipment to include but not limited to safety glasses and safety gloves.
  • Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions.
  • Prior experience with the release and disposition of nonconforming products through the application of risk assessment and root cause analysis tools.
  • Demonstrated validation proficiency, with knowledge of product, process and equipment qualifications and validations (IQ/OQ/PQ).
  • Good data analysis skills, with an ability to use statistical methods to conduct quality investigations.
  • Lean Sigma Green or Black Belt certified a plus.
  • ASQ CQE a plus.
  • Excellent organizational skills with strong attention to detail.
  • Ability to multitask efficiently to support production demand.
  • Computer skills: knowledge of Microsoft Office applications (Word, Excel, and PowerPoint) is a must.

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