Quality Engineering Manager
I am working with a Medical Device company who is looking for a Quality Engineering Manager to lead product quality from NPD to Post Market.
This will have a huge focus on electromechanical products.
- Oversee Quality Engineering support throughout all phases of the product development life cycle including quality support for R&D and NPI, and the way through manufacturing activities
- requirement development, specification development, verification and validation testing, design transfer, risk assessment, usability, design change control
- Risk Management processes, updating risk files. Participate and contribute to the development of product design history file and ensure compliance to internal processes and external standards and regulation
- Have ownership of products adhering to IEC 60601 and IEC 62304.
- Design Transfers
- Lead a team of Quality Engineers
Requirements
4+ years of experience working with electro-mechanical medical devices, Software as a Medical Device, and Electrical devices.
robotics, or medical software is highly desired
- Experience in Quality, Manufacturing, or Research and Development experience in a medical device industry
- Strong knowledge of FDA requirements for design control of medical devices and 21 CFR 820, ISO 13485, 14971; IEC 60601-1, IEC 62304 medical device software, cybersecurity, and related regulations
Senior Manager of Quality Engineering
A company is looking for a Senior Manager, Quality Engineering to lead their quality engineering team. ...
Senior Manager, Quality Engineering - Device Software
Under the general guidance of the Director, Quality Engineering, this Senior Manager, Quality Engineering - Device Software position manages the Quality activities related to ICU Medical Device Software Development, Testing, and Release, within Device Engineering and the Corporation assuring that pr...
Sr Manager/Director, Customer Quality Engineering
Master of Science in electrical engineering, computer engineering, software engineering, computer science or equivalent required. This role will lead a team of customer quality engineers located globally, interact with customers, senior and executive management, building excellent technical partners...
Manager, Quality Engineering
Creates, implements, and manages a Quality Program and team of Quality Engineers in partnership with other cross functional team members (30%). Primarily responsible for development and managing the administration aspect of TD SYNNEX’s Quality Program. Oversees the collection and analyzing of qualit...
Engineering Manager - Hardware Design Quality.
Bachelors Degree in Engineering or Science field with 5+ years of experience in quality and/or engineering management. Masters Degree in Engineering or Science field with 3+ years of experience in quality and/or engineering management. Certifications in Quality Engineering, Quality Management or Pro...
Manager, IT Quality Assurance Engineering
The Manager, Quality Assurance is responsible for developing, leading, and executing the test automation best practices strategy through planning, coordinating, and supervising all activities related to the design, development, and implementation of test automation. This position collaborates with o...
Quality Engineering Manager
Quality Engineering Manager, you will be responsible for developing a world class quality department and driving plant wide continuous improvement that results in unparalleled quality performance. This position will be responsible for managing, coordinating and administering all functions of the sit...
Quality Engineering Manager
Regal Rexnord PSI is a leading supplier in the Aerospace industry, is seeking a Quality Engineering Manager, who will be based at our Simi Valley, California manufacturing facility, will provide superior tactical and strategic implementation of the quality system and supporting quality programs. ASQ...
Sr Manager, IT Quality Engineering
As a Sr Manager, IT Quality Engineering you are responsible for working closely with business leads and other IT partner functions to develop and maintain in-depth understanding of business needs and objectives in both business and technology realms. Supports and maintains the principles and practic...
Quality Engineering Manager (Software)
EnFin is seeking a highly skilled and motivated Quality Engineering Manager to lead our software quality assurance and testing efforts. Extensive knowledge and experience of Quality Assurance Engineering principles, Software engineering in test methodologies, and tools in Software/SaaS environments ...