- Support validation process through protocol drafting, approval and execution and providing validation training and guidance
- Chair Process Change Review Board and participate in Validation Review Board meetings
- Participate in Design Transfer/Change Control projects as the Quality Assurance Core Team Lead
- Lead improvement initiatives for Quality Assurance
- Independently perform full range of standard work
- Identify and resolve more complex problems and apply problems-solving skills to handle most situations
- Use statistical analysis and risk management techniques
- Provide guidance for process changes, including guidance on validation requirements
- Lead CAPA investigations
- In depth working knowledge and practical application of process validation requirements (IQ/OQ/PQ) and TMV, with ability to develop and support creation of protocols and reports
- Proven ability to lead projects
- In-depth knowledge of requirements related to ISO 13485 and FDA QSR
- Strong knowledge of Risk Management and Design Controls/Design Transfer/Change Control
- Experience with product transfers and new product development projects
- Experience with problem solving techniques and CAPA investigations
- Strong organizational skills and ability to prioritize
- Experience working in medical device or regulated industry
- Proficient with Microsoft Excel, including use of pivot tables
- Perform statistical analysis using standard software such as Minitab
- Ability to make decisions and communicate effectively to multiple levels
- Bachelor's degree in science or engineering field of study
- Certified Quality Engineer (CQE) Six Sigma Certification experience preferred
- 5-8 years of successful experience in medical device and quality engineering, and successful demonstration of Responsibilities and Knowledge as listed above
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Quality Engineer
3 weeks ago
Ampcus Flanders, United StatesPosition Overview · This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional teams to determine validation activities required for pr ...
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Quality Engineer
2 weeks ago
Ampcus Flanders, United StatesPosition Overview · This position is for a Quality Engineer, reporting to the Sr. Quality Manager, with primary responsibility for Process Validation activities in manufacturing. This person will work with cross functional teams to determine validation activities required for pro ...
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Quality Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Flanders, United StatesResponsibilities: Support validation process through protocol drafting, approval and execution and providing validation training and guidance Chair Process Change Review Board and participate in Validation Review Board meetings Participate in Design Transfer/Change Control projec ...
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Quality Engineer
2 days ago
Nebula Ventures Montclair, United StatesTHE ASAP GROUP · What makes us great? The people of the ASAP Group. · With a focus on future-oriented technologies, we have quickly become a top engineering partner. As an independent subsidiary of the global player HCLTech, we combine stability with an innovative mindset. · Are ...
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Quality Engineer
2 days 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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Supplier Quality Engineer 3
3 weeks ago
Katalyst Healthcares and Life Sciences Flanders, United StatesResponsibilities: Lead initiatives to improve quality received from assigned suppliers. Support the qualification of parts and/or introduction of new suppliers. Manage supplier's corrective action implementation through the Supplier Corrective Action process. Evaluate and disposi ...
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Quality Engineer
2 weeks ago
Howmet Corporation Dover, United StatesResponsibilities · Howmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance ...
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Quality Engineer
3 weeks ago
Howmet Aerospace Dover, United StatesResponsibilitiesHowmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance par ...
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Quality Engineer
1 week ago
Howmet Corporation Dover, United StatesResponsibilities · Howmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance ...
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Quality Engineer
2 weeks ago
Howmet Corporation Dover, United StatesResponsibilities · Howmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance ...
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Quality Engineer
2 weeks ago
Howmet Aerospace Dover, United StatesResponsibilities · Howmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance ...
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Quality Engineer
1 week ago
Howmet Corporation Dover, United StatesResponsibilities · Howmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance ...
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Quality Engineer
3 weeks ago
Howmet Corporation Dover, United StatesResponsibilities · Howmet Engines is a world-class producer of aero engine and industrial gas turbine components, including airfoils, rings, disks and forgings. We excel in vacuum melted superalloys, machining, performance coatings and hot isostatic pressing for high performance ...
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Quality Engineer
1 week ago
UnitedHealth Group Basking Ridge, United StatesWork collaboratively with cross-functional teams, including Product Owners, Architects, and Developers, to define and refine quality assurance practices for a Master Data Management system focusing on Patient Identity Develop and maintain detailed te Quality Engineer, Engineer, R ...
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Engineer, Quality
1 week ago
Marotta Controls Parsippany, United StatesCome grow with Marotta One of NJ's fastest growing technology companies, named a New Jersey Top Workplace for 2022 & 2023, and a "Made in New Jersey" Manufacturer of the Year Award Winner. You will have room to grow and be a part of an exciting team, all within a warm and welcom ...
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Quality Engineer
2 weeks ago
Valcor Engineering Corporation Springfield, United StatesResponsible for Quality Assurance activities at the Valcor Engineering Corp. performing specialized, complex and involved assignments of a Quality engineering nature having to do with development and administration of quality control procedures and techniques. These include: · E ...
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Quality Engineer
3 weeks ago
Coda Search│Staffing Hawthorne, United StatesJob Summary: · The Quality Engineer is an essential member of our Quality Assurance Department responsible for ensuring that quality systems are properly established and maintained for effective and efficient internal compliance and customer satisfaction. The responsibilities of ...
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Quality Engineer
3 weeks ago
Cummins Convent Station, United StatesCummins Inc. · Quality Engineer · in · Morristown , · Tennessee · Quality Engineer · Description · Quality Engineer · Our culture believes in · POWERING YOUR POTENTIAL · . We provide global opportunities to develop your career, make your community a better place and work w ...
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Quality Engineer
3 weeks ago
KLM Careers Convent Station, United StatesQuality Engineer - TN · Morristown, TN · Must be a US Citizen or Green Card holder. · This position develops and executes validation protocols (IQ / OQ / PQ) · as required for equipment, sanitization/cleaning, facilities, software, · and processes. This job will also work with ...
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Quality Engineer
2 weeks ago
Valcor Engineering Corporation Springfield, United StatesJob DescriptionJob Description · Valcor Engineering is looking for Quality Engineers to become a part of our Team. We are a world class designer and manufacturer of custom precision fluid controls, motion controls, and turnkey systems for space, aircraft, nuclear, and · scienti ...