![Katalyst Healthcares and Life Sciences](https://media.trabajo.org/img/noimg.jpg)
Quality Engineer
3 months ago
- 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
We have other current jobs related to this field that you can find below
-
Quality Engineer
2 months ago
Flanders, United States Ampcus Full timePosition 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 projects as well as engineering and process changes. This person will support the...
-
Corporate Quality Engineer
3 days ago
Flanders, United States Benjamin Moore Full timeAt Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a rewarding and inspiring work environment that fosters creativity, collaboration, and a strong sense of camaraderie. Our culture of excellence and transparency encourages our colleagues to bring their authentic selves and unique...
-
Quality Control Inspector
1 month ago
Flanders, United States Birk Manufacturing Inc. Full timeJob DescriptionJob DescriptionDescription:POSITION SUMMARY As a member of the Birk Manufacturing Quality Control team you will be responsible for inspecting, measuring and testing individual products to Birk Manufacturing and/ or customer specifications and requirements. This includes, but is not limited to, incoming inspection of raw material, in-process...
-
Design Engineer
3 months ago
Flanders, United States Birk Manufacturing Inc. Full timeJob DescriptionJob DescriptionDescription:Summary/ObjectiveThe design Engineer is responsible for product design, creating production packages, and process development that help meet customer product requirements. The are responsible for designing circuitry and creating engineering drawings using AutoCAD. They are also responsible for managing projects and...
-
Sr Commercialization Engineer
3 weeks ago
Flanders, United States Benjamin Moore Full timeSr Commercialization EngineerID 2024-1477Category EngineeringPosition Type SalariedRemote NoShift Time 8am-5pmLocation FlandersOverviewAt Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a rewarding and inspiring work environment that fosters creativity, collaboration, and a...
-
Senior Commercialization Engineer
6 days ago
Flanders, United States Benjamin Moore Full timeAt Benjamin Moore, we empower our team members to achieve their goals and make a positive impact in our communities. We offer a rewarding and inspiring work environment that fosters creativity, collaboration, and a strong sense of camaraderie. Our culture of excellence and transparency encourages our colleagues to bring their authentic selves and unique...