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Rang Technologies Inc · 1 week ago
Quality Engineer
Chelmsford, MA
Contract
Onsite
Senior Level
$30/hr - $35/hr
6+ years exp
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Hiring Manager
Vikram Sandhu
Insider Connection @Rang Technologies Inc
Responsibilities
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 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 support 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.
Qualification
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Required
Bachelor of Science (BS) Degree in a scientific/Engineering discipline. Graduate degree (MS) also a plus.
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.
Experience in processes and procedures of ISO-9001: 2015 (ISO 13485 preferred) and DEA
Ability to work in a matrix organization.
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 product 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.
Excellent organization skills with strong attention to details.
Ability to multitask efficiently to support production demand.
Computer skills: knowledge of Microsoft Office applications (Word, Excel and PowerPoint) is a must.
Preferred
Lean Sigma Green or Black Belt certified a plus.
ASQ CQE a plus.
Company
Rang Technologies Inc
Headquartered in New Jersey, Rang Technologies has dedicated over a decade delivering innovative solutions and best talent to help businesses get the most out of the latest technologies in their digital transformation journey.
201-500 employees
H1B Sponsorship
Rang Technologies Inc has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (15)
2022 (26)
2021 (31)
2020 (27)
Funding
Current Stage
Growth StageLeadership Team
Dilip Patel
President, Founder and CEO
Company data provided by crunchbase
