Job Description: 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.
Requirements Knowledge - Skills:
" Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline. Graduate degree (MS) 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 product 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 organization skills with strong attention to details.
" Ability to multitask efficiently to support production demand.
" Computer skills: knowledge of Microsoft Office applications (Word, Excel and PowerPoint) is a must.
Comments for Suppliers: Monday - Friday 8:00am - 5:00pm