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Quality Engineer
6 days ago
Saxon Global Raynham, United StatesMANDATORY SKILLS - product manufacturing quality in casting/ injection molding/ machining 'Major Responsibilities & Duties: Business Improvements - Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. - ...
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Quality Engineer
5 hours ago
Insight Global Raynham, United StatesThe Quality Engineer will be participating in manufacturing readiness activities. This is not NPI/full scale process validation, but we are introducing systematically new codes. There will be some business and quality systems work. The primary objective will be a gap assessment a ...
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Quality Engineer
1 day ago
Insight Global Raynham, United StatesThe Quality Engineer will be participating in manufacturing readiness activities. This is not NPI/full scale process validation, but we are introducing systematically new codes. There will be some business and quality systems work. The primary objective will be a gap assessment a ...
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Quality Engineer
3 weeks ago
Kaztronix Raynham, United StatesJob DescriptionJob Description · Must Haves: · Minimum of B.S. In Engineering · 5 + yrs. of experience in Med Device (Ortho preferred) environment as a Quality Enigneering and/or Validation rolepreferred in medical device company with active class III devices · Proficient at ...
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Quality Engineer
3 weeks ago
Aurora Ventures Warwick, United StatesYour Responsibilities · Manage suppliers specializing in non-corrosive and tool steels · Execute and monitor qualification and supplier approval processes · Collaborate with the product development team · Review and create specifications and quality-related documents · Your Profi ...
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Quality Engineer
1 day ago
Velocity Solutions North Walpole, United StatesAbout the Company · As a system partner of the office furniture industry, we specialize in the development and production of functional fittings made of metal and plastic. As one of the leading companies in Europe, we strive to quickly and flexibly fulfill individual customer req ...
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Quality Engineer
1 day ago
Spectrum Industries Cambridge, United StatesDigital transformation. Sustainability. Peacekeeping. Exciting tasks that we at Diehl, in our five subgroups Metall, Controls, Defence, Aviation, and Metering, and our over employees are working on with high pressure. Discover fascinating technologies and apply now. In a family-o ...
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Design Quality Engineer
3 weeks ago
IntePros Raynham, United StatesDesign Quality Engineer: · We are seeking a Design Quality Engineer to join our team. The ideal candidate will have a deep understanding of design quality, process verification, gap assessment, supplier quality, and new product development. You will be responsible for reviewing d ...
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Design Quality Engineer
2 weeks ago
IntePros Raynham, United StatesDesign Quality Engineer: · We are seeking a Design Quality Engineer to join our team. The ideal candidate will have a deep understanding of design quality, process verification, gap assessment, supplier quality, and new product development. You will be responsible for reviewing d ...
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quality engineer
1 week ago
SINCLAIR MANUFACTURING COMPANY LLC Norton, United StatesJob Description · Job DescriptionDescription:Responsible for providing support for the following Quality tasks and duties: introduction and launching of new or improved products and processes into the plant. Lead problem-solving teams. Facilitate from a Quality & Quality Engineer ...
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Quality Assurance Engineer
2 weeks ago
CPS Technologies Corp. Norton, United StatesBASIC FUNCTION: · Function as a lead member of the CPS Quality Assurance Team in supporting CPS Operations to ensure that our products always meet the requirements of our customers · MINIMUM REQUIREMENTS: · Understanding of ISO 9001 Quality Management System requirements · Compet ...
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Resident Construction Inspector
1 week ago
Stacey DePasquale Engineering, Inc. Raynham, United StatesThe current project requires knowledge of vertical construction within Water Treatment Plants. This project is set to begin in July and run approximately 5 months. · The inspector shall have 10+ years construction oversight experience in the water, sewer, and/or storm water indus ...
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Supply Chain Launch Lead
3 weeks ago
Johnson & Johnson Raynham, United States**Johnson & Johnson **is currently recruiting for a **Supply Chain Launch Lead **in Raynham, MA. · **As part of the Supply Chain Product Management team, **this individual will join the DePuy Synthes Joint Reconstruction group supporting the Shoulder platform. They will be the en ...
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Quality Engineer
5 days ago
Jobot Mansfield, United StatesQuality Engineer - Leading Innovative Manufacturing Provider This Jobot Job is hosted by: Sam Sanchez Are you a fit? Easy Apply now by clicking the "Apply" button and sending us your resume. Salary: $90,000 - $115,000 per year A bit about us: Based in Mansfield, MA with five more ...
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quality engineer
5 days ago
Jobot Mansfield, United StatesQuality Engineer - Leading Innovative Manufacturing Provider · This Jobot Job is hosted by: Sam Sanchez · Are you a fit? Easy Apply now by clicking the Apply button · and sending us your resume. · Salary: $90,000 - $115,000 per year · A bit about us: · Based in Mansfield, M ...
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Quality Engineer
1 week ago
Spark Talent Inc Plymouth, United StatesJob Description · Job Description · Job Title: Quality Engineer Job Post · About the CompanySpark Talent Acquisition is a Michigan-headquartered recruiting and staffing company that connects great talent with great employers. We understand that finding a new position can be stres ...
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Quality Engineer
2 weeks ago
Wagner Plymouth, United States Regular, Full timePosition Objective: · Assure Wagner Spray Tech products conform to specifications set forth in engineering documentation, while operating in the most cost-effective manner. Through active participation and involvement, lead efforts to support supplier development creating proces ...
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Quality Engineer
1 week ago
Webasto Plymouth, United StatesFeel the Drive – for us that means making mobility something you can experience with all your senses. We work for more comfort, wind in your hair, the perfect temperature in every season and driving with a clear conscience - for a safe and sustainable future. · We make mobility f ...
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Quality Engineer
1 week ago
Katalyst HealthCares & Life Sciences Plymouth, United StatesResponsibilities : to years of experience in QA systems implementation and management in manufacturing environment. · Preferred Automotive Industry experience · Broad knowledge of theory and principles of statistics and statistical process control. · Bachelor's degree Mechan ...
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Quality Engineer
2 weeks ago
Integer Holdings Plymouth, United States Regular, Full timeBy living according to a common set of values, we create a culture that unifies, embraces the uniqueness we all bring to the company, and positions Integer for long-term success. · At Integer, our values are embedded in everything we do. · Customer · We focus on our customers' s ...
Quality Engineer - Raynham, United States - Cynet Systems
Description
Job Description:
Responsibilities:
Business Improvements:
Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements. Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques, and/or other improvement tools and programs.
Conduct benchmarking to develop more effective methods for improving quality Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
Compliance/ Regulatory:
Review/analyze whether current products and processes (including actions or decisions conducted) comply with standards such as the QSRs, ISO 13485, etc.
Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN, and Medical Device Directive (MDD) requirements) including providing support during internal and external audits. Conduct periodic line audits to assess for production controls such as lot segregation. Review results of area audit to ensure that corrective and preventive actions are adequate. New Product/ Process Introduction.Partners with R&D and other cross-functional partners to ensure the proper application of design controls, risk management, and the investigation/correction of design failures/challenges.
Supports new product introduction as part of design transfer. Product Quality, Control & Disposition and Performance Standards Supports activities related to the Material Review Board. Conduct investigation, bounding, documentation, review, and approval of non-conformances, CAPAs, and customer complaints. Escalation of quality issues as appropriate.ccountability and ownership for material identification, material segregation, and classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
nalyze/review the effectiveness of preventive and corrective actions. Review root cause investigation according to an established process. ccountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality. Production/ Process Controls including Control Plans.Partners with Global Supply chain, Finished Goods, and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk. Collect data and execute/conduct various analytical/statistical analyses and interpretations as part of process improvements and day-to-day support. Develop, interpret and implement standard and non-standard sampling plans. ssess the effectiveness of measurement tools, destructive tests, non-destructive tests, and measurement system analysis. ssess and interpret common versus special cause variation in manufacturing processing and determine the adequacy of current process limits.Risk Mitigation:
Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond the capability of current controls or whether a change will result in potential non-compliance to a required standard such as the QSRs.
ssess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
Determine effectiveness of these techniques on previously implemented improvements. Strategic. Ensures effective quality strategies are created for the validation of test methods, processes, and design.Qualifications:
minimum of a Bachelors Degree, preferably in Engineering or related technical field. Require 2 to 4 years of relevant experience. Experience working in both an FDA and European regulatory environment is required. This position will require relevant experience working in manufacturing/operations. In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required. Experience with a proven track record of implementing appropriate risk mitigation.
Technical training and experience using Statistics, Lean, and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
Strong knowledge of statistical software packages is preferred with the ability to preview, graph, and analyze data and be able to present data that facilitates/drives decision-making.
The ability to perform "hands-on" troubleshooting and problem-solving is preferred. The ability to think on the feet and provide sound judgment is highly desired. Good technical understanding of manufacturing equipment and processes is required. Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred. thorough understanding of GMP/ISO regulations and validation regulations is preferred.