- Medical Device
- Design Quality Engineering
- Design Controls / FMEA / SFMEA
- Risk management
- Remediation Experience
- IEC 62304 & IEC 60601
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Quality Engineer
1 week ago
Aurora Ventures Union, United StatesAbout Osbra GmbH: · We are a medium-sized, future-oriented family business located in the Unterallgäu region. For over 40 years, we have been supplying leading automotive manufacturers with innovative plastic parts for both interior and exterior use. Our focus is on smaller and m ...
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Quality Engineer
1 week ago
Radiant Enterprises Woodside, United States Full timeAbout Woodside: · We are a medium-sized, future-oriented family business located in the Unterallgäu region. For over 40 years, we have been supplying leading automotive manufacturers with innovative plastic parts for both interior and exterior use. Our focus is on smaller and med ...
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mechanical/quality engineer
2 weeks ago
A & A Company South Plainfield, United StatesA&A Coatings a Thermal Spray Coating company of South Plainfield, NJ is seeking to immediately fill the Full-Time position of a Mechanical/Quality Engineer. · RESPONSIBILITIES: · Create job routers in ERP system based on manufacturing process requirement. · Create supporting docu ...
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Supplier Quality Engineer
1 day ago
Katalyst HealthCares & Life Sciences South Plainfield, United StatesRoles and Responsibilities: · Collaborate with cross-functional teams to establish quality and performance metrics for suppliers. · Establish regular connects with supplier to evaluate Material changes to Parts/Components and decide the implementation actions. · Monitor and track ...
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Quality Engineer Electrical Engineering
1 week ago
Stellar Enterprises Hudson, United StatesIn our development department, you can expect excellent prospects in a technologically exciting growth industry. Use your ideas with state-of-the-art machines and methods and continuously develop your skills. · Your tasks: · Formulation of quality requirements for electronic pr ...
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Quality Engineer
2 days ago
GNY Insurance Companies Edison, United StatesJob Details · Job Location NEW JERSEY - EDISON, NJ Remote Type Fully Remote Description · Travel to the New Jersey and New York locations 25% of the time is required. · Position Summary: · The Quality Engineer will work in collaboration with the development team to ensure GNY b ...
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Supplier Quality Engineer
1 week ago
Rosa Experts New York, United States> · Erweiterte Suche · > · offene Stellen · > · (w/m/d) · Überprüfung und Reporting der fach- und termingerechten Fertigungsausführung von Anlagenkomponenten bei Unterlieferanten vor Ort · Durchführung von Qualitätsprüfungen und Funktionsproben einschließlich der Erstellung ...
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Quality Engineer
2 days ago
GREATER NEW YORK MUTUAL INSURANCE COMPANY Edison, United StatesJob DetailsJob LocationNEW JERSEY - EDISON, NJRemote TypeFully RemoteDescriptionTravel to the New Jersey and New York locations 25% of the time is required.Position Summary:The Quality Engineer will work in collaboration with the development team to ensure GNY business needs are ...
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quality engineers
1 week ago
INTELLECTT INC Iselin, United StatesQUALITY ENGINEERS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Work on prod perf specs & dsgn chngs. Create, & update Failure Mode & Effects Analysis (DFMEA) for new implants & instruments. Impl CAPA actions to prevent nonconform ...
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quality engineers
1 week ago
Shoolin Iselin, United StatesQUALITY ENGINEERS - Shoolin, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U.S: Work on prod perf specs & dsgn chngs. Create, & update Failure Mode & Effects Analysis (DFMEA) for new implants & instruments. Impl CAPA actions to prevent nonconformanc ...
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Quality Engineering Technician
1 week ago
Infinity Ventures Hill City, United States**About Häfele Schneider GmbH & Co KG: ** · As a system partner for 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 fulfil ...
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quality engineers
1 week ago
INTELLECTT INC Iselin, United StatesWork on product performance specifications and design changes. Create, and update Failure Mode and Effects Analysis (DFMEA) for new implants and instruments. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards. Develop Approa ...
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quality engineers
1 week ago
Shoolin Iselin, United StatesWork on product performance specifications and design changes. Create, and update Failure Mode and Effects Analysis (DFMEA) for new implants and instruments. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards. Develop Approa ...
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quality engineers
2 weeks ago
INTELLECTT INC Iselin, United StatesWork on product performance specifications and design changes. Create, and update Failure Mode and Effects Analysis (DFMEA) for new implants and instruments. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards. Develop Approa ...
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Junior Quality Assurance Engineer
1 week ago
Horizon Ventures Monmouth Junction, United StatesJunior Quality Assurance Engineer (m/w/d) in Monmouth Junction · You are in the right place at a leading company for software innovations. The innovative team in Monmouth Junction sets standards in the development of groundbreaking solutions for optimizing business processes. We ...
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Senior Quality Engineer for Electromobility
1 week ago
BlueWave Solutions Little Silver, United StatesWith our brands BMW, MINI, Rolls-Royce, and BMW Motorrad, we are one of the world's leading premium manufacturers of automobiles and motorcycles, as well as providers of premium financial and mobility services. · For the company division Engineering - E-Mobility Development Engi ...
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Aerospace Quality Engineer
1 day ago
Ferco Aerospace Plainfield, United StatesJob Description · Job DescriptionAs a Quality Engineer, you have the chance to make a considerable difference in the quality, superiority and reliability of our products. Your responsibilities will be centered around analyzing, testing and reporting on a product's overall functio ...
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Quality Assurance Engineer
1 week ago
Orion Innovation Edison, United StatesOrion Innovation is a premier, award-winning, global business and technology services firm. Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, an ...
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Quality Engineer
1 week ago
Intelliswift Software Inc Berkeley Heights, United StatesPay rate range: $38/hr. to $40/hr. on w2. · Bilingual, Korean Native Proficiency is must · 2+ years of directly related experience is required in Android testing · MS Office Expert- MS Excel, Word, MS PowerPoint · Summary: · The main function of a SW Quality Engineer is to ...
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Automated Quality Assurance Engineer
4 days ago
MouthWatch, LLC Metuchen, United StatesAbout Us: · MouthWatch is leading the charge in Teledentistry, continuously pushing the boundaries of what is possible in virtual dentistry applications. As an Automated Quality Assurance Engineer, you will be responsible for designing and developing the suite of tests that ensu ...
Design Quality Engineer - South Plainfield, United States - Katalyst Healthcares and Life Sciences
Description
Design Quality EngineerEnvironment: Our client is a large medical device manufacturer that develops a number of Medical Device products. They are currently in need of an experienced Design Quality Engineer to support remediation activities surrounding risk management and design FMEAs as well as SFMEAs.
Responsibilities:
This role's emphasis is for supporting remediation of existing risk management and design control activities. Additionally, the role may include supporting risk management and design control related procedure updates. This person will be responsible for leading, conducting, and owning risk management activities including hazard analysis, system risk analysis, and various FMEAs as well as ensuring compliance to ISO 14971 and implementation of risk management best practices, that design controls are compliant with all relevant regulations, and that FDA and other regulatory knowledge and experience is applied to risk and testing assessments. Responsibilities will also include supporting design quality engineering activities in support of product development and life cycle processes including design controls, quality planning, risk management assessments, design reviews, test method development and validation, design verification and validation test plans and reports.
This individual should have experience contributing to the design, development, and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance as well as developing statistically sound sampling plans and perform data analysis. They should also be comfortable working with manufacturing engineering to ensure necessary process controls are in place for initial product launch and significant design changes and reviewing and approving change requests and Engineering Change Orders (ECO) as needed.
Required:
