Manufacturing Quality Engineer

3 weeks ago

Chelmsford, United States TekWissen ® Full time

Position: Manufacturing Quality Engineer

Location: Chelmsford, MA - 01824

Duration: 6 Months

Job Type: Contract

Work Type: Onsite

Shift: Monday to Friday 08:00 AM to 05:00 PM

Pay Rate: $25 to $32/hr


Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries worldwide. The job opportunity below is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.


Please Note: This is not a Software Quality Engineer position. This is a Manufacturing Quality Engineer role.


Job Summary:

  • As a Quality Engineer, you will have the opportunity to support a life science manufacturing facility by 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.
  • Troubleshoot electrodes and buffer solutions.
  • Implement corrective and preventative actions (CAPAs) to prevent the recurrence of deviations and nonconformances.
  • Verify the effectiveness of implemented changes utilizing the proper quality tools.
  • Guide 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 expert knowledge of Quality tools such as FMEA, risk analysis, validation principles, sampling plans, Six Sigma, and control plans.
  • Lead and generate 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 supports improvement efforts, implements changes, and verifies effectiveness of changes.
  • Support internal and external audits, customer audits, and supplier audits.
  • Perform Quality Assurance (QA) responsibilities as needed to support manufacturing activities and material release.
  • Write or revise standard quality control operating procedures and quality system documentation as required.
  • Write technical reports such as investigation summary reports and change management records.

Requirements – Knowledge - Skills:

  • Minimum: Bachelor of Science (BS) Degree in a scientific/Engineering discipline.
  • 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 communication 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 including 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 certification is a plus.
  • ASQ CQE is a plus.
  • Excellent organization 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.


TekWissen® Group is an equal-opportunity employer supporting workforce diversity.

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