Manufacturing Quality Engineer
Manufacturing Quality Engineer
Posted on :
13-06-2024
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Posted on :
13-06-2024
Job Description
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 clients global team is committed to delivering an unparalleled blend of cuttingedge technologies convenient procurement options and pharmaceutical services under their industryleading brands.
Position: 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
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 outofspecification conditions of our local factory and suppliers by applying various root cause analysis (RCA) methods and tools such as Cause and Effect Diagrams 5Whys 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 nonconforming 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 riskbased 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 sites 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 ISO9001: 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 followup.
- Strong analytical problemresolution judgment and decisionmaking 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 equalopportunity employer supporting workforce diversity.
Employment Type
Full Time
Key Skills
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