JobsUSASr Quality Engineer
Company : Katalyst HealthCares & Life Sciences
Location : Irvine, CA, 92713
Posted Date : 15 September 2025
Job Type : Other
Category : Industrial Engineering
Occupation : Quality Engineer
Job Details
- Perform New Product Development of Surgical Medical Devices in this division, We are looking for an Engineer to perform & work mainly on Quality Tasks.
- Create, test, and/or improve products by developing moderately complex experiments and tests (including writing and executing protocols), analyze results, make recommendations, and develop reports, based on engineering principles.
- Driving process and equipment validations (ex. TFIQ, IQ, OQ, PQ).
- Drafting, approving, executing, and maintaining all relevant documentation (ex. SOPs, operator training, specifications, drawings, process sheets, FMEAs, and validation plans).
- Create/update portions of design control documents including requirement specs and risk documents.
- ssign R&D support tasks; give instruction to technicians on conducting tests; train technicians and provide feedback; and coordinate technician work.
- Identify, evaluate, manage, and provide guidance to suppliers, including establishing tolerances and defining acceptance criteria for suppliers.
- Other duties assigned by Leadership.
- Bachelor's degree in engineering or Scientific field & 4+ years' experience -OR- Master's Degree or equivalent in Engineering or Scientific field & 3+ years' experience.
- CAD experience (Solidworks -or- Creo).
- Statistical based software (Minitab, JMP).
- Keyence, and Other Inspection Methods.
- Data Analysis (Stat), 3D modeling.
- Drawing Review and Inspection.
- Medical Device experience is strongly preferred.
- Experience in test method development including Fixture development and Validation.
- Basic understanding of statistical techniques.
- Develop, update, and maintain technical content of risk management files.
- Understanding and knowledge of principles, theories, and concepts relevant to Engineering.
- Solid problem-solving, organizational, analytical, and critical thinking skills.
- Good documentation, communication (e.g., written and verbal), and interpersonal relationship skills including consultative and relationship management skills.
- bility to interact professionally with all organizational levels & time management.
- bility to manage competing priorities in a fast-paced environment.
- bility to build productive internal/external working relationships.
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