Quality Assurance Engineer in Manufacturing
3 weeks ago
Position: Quality Engineer
Location: Chelmsford, MA
Duration: 6 Months
Job Type: Contract
Work Type: Onsite
Shift: Monday to Friday, 08:00 AM to 05:00 PM
Job Summary:
- As a Quality Engineer, you will play a crucial role in supporting a life sciences manufacturing facility by serving as a subject matter expert in Quality Engineering.
- Your contributions will include conducting root cause analyses (RCAs) and implementing corrective and preventive actions (CAPAs) to achieve effective resolutions.
- You will also provide quality leadership to enhance Critical to Quality (CTQ) parameters, supporting overall site improvement initiatives.
- Investigate process and product deviations as well as out-of-specification conditions at our local manufacturing site and among suppliers, utilizing various root cause analysis methods and tools such as Cause and Effect Diagrams and 5 Whys.
- Ensure compliance with DEA regulations and act as a CSP coordinator.
- Address customer complaints with professionalism and efficiency.
- Troubleshoot issues related to electrodes and buffer solutions.
- Implement CAPAs to prevent the recurrence of deviations and nonconformances.
- Verify the effectiveness of implemented changes using appropriate quality tools.
- Guide the disposition of nonconforming materials, including both final products and raw materials.
- Conduct statistical analyses to monitor process and product performance, responding to negative trends as necessary.
- Lead change controls for complex improvement projects, employing risk-based methodologies.
- Possess expert knowledge of quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
- Lead and generate risk assessments, including product and process FMEAs.
- Demonstrate strong knowledge of process, product, and equipment validation principles, including the generation of protocols and reports, creation of acceptance criteria, establishment of proper sampling plans, and completion of statistical analyses.
- Maintain the site's Quality Systems in compliance with ISO standards and regulatory requirements.
- Drive continuous improvements across all areas, supporting enhancement efforts, implementing changes, and verifying their effectiveness.
- Support internal and external audits, including customer and supplier audits.
- Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
- Draft or revise standard quality control operating procedures and quality system documentation as required.
- Prepare technical reports, such as investigation summary reports and change management records.
- Minimum: Bachelor of Science (BS) Degree in a scientific or engineering discipline.
- A graduate degree (MS) is also advantageous.
- A minimum of 6 years of prior experience in a Quality Engineering role, preferably within a cGMP Biotech or Life Science environment.
- Proven experience with titrators and pH testing.
- Strong verbal and written communication skills in English.
- Ability in technical and statistical writing.
- Experience with ISO 9001:2015 (ISO 13485 preferred) and DEA processes and procedures.
- Ability to work effectively in a matrix organization.
- A fundamental understanding of quality systems and their development, documentation, and implementation concerning domestic and international standards.
- 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, including but not limited to safety glasses and gloves.
- Demonstrated ability to conduct quality investigations, including root cause analysis and determining corrective/preventive actions.
- Prior experience with the release and disposition of nonconforming products through 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 the ability to utilize statistical methods for quality investigations.
- Lean Sigma Green or Black Belt certification is a plus.
- ASQ CQE certification is a plus.
- Excellent organizational skills with strong attention to detail.
- Ability to multitask efficiently to meet production demands.
- Computer skills: proficiency in Microsoft Office applications (Word, Excel, and PowerPoint) is essential.
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