Quality Assurance Engineer in Manufacturing

3 weeks ago

Chelmsford, Essex, United Kingdom TekWissen LLC Full time
Overview: TekWissen Group is a global workforce management provider, delivering innovative solutions across various sectors. The following opportunity is with one of our esteemed clients, a leader in biotechnology product development services. This organization is committed to providing essential laboratory equipment, chemical supplies, and services that are vital for healthcare, scientific research, safety, and education. With an impressive annual revenue of approximately $40 billion, our client is dedicated to empowering customers to create a healthier, cleaner, and safer world. Their global team excels in offering a unique combination of advanced technologies, convenient procurement options, and pharmaceutical services under renowned industry brands.

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, 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 problem resolution.
  • You will also provide quality leadership to enhance Critical to Quality (CTQ) parameters, supporting overall site improvement initiatives.
Essential Functions:
  • Investigate process and product deviations, as well as out-of-specification conditions, by utilizing various root cause analysis methods and tools such as Cause and Effect Diagrams and 5 Whys.
  • Ensure compliance with regulatory standards and act as a coordinator for compliance-related activities.
  • 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 using risk-based methodologies.
  • Possess expert knowledge of quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
  • Generate and lead risk assessments, including product and process FMEAs.
  • Demonstrate strong knowledge of validation principles related to processes, products, and equipment.
  • Maintain the site's Quality Systems in accordance with ISO standards and regulatory requirements.
  • Drive continuous improvement initiatives across all areas, supporting efforts to implement changes and verify their effectiveness.
  • Assist with internal and external audits, including customer and supplier audits.
  • Perform Quality Assurance responsibilities as needed to support manufacturing activities and material release.
  • Write or revise standard operating procedures and quality system documentation as required.
  • Prepare technical reports, including investigation summaries and change management records.
Requirements Knowledge Skills:
  • Minimum: Bachelor of Science (BS) Degree in a scientific or engineering discipline.
  • A graduate degree (MS) is a plus.
  • 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.
  • Fundamental understanding of quality systems and their development, documentation, and implementation in line with domestic and international standards.
  • Understanding of the audit process, including planning, preparation, execution, reporting results, and follow-up.
  • Strong analytical, problem-solving, judgment, and decision-making skills.
  • Operation requires the use of safety equipment, including 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 proficiency in validation, including knowledge of product, process, and equipment qualifications and validations (IQ/OQ/PQ).
  • Good data analysis skills, with the ability to use 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.
TekWissen Group is an equal opportunity employer, supporting workforce diversity.

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