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Quality Engineer
1 month ago
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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