Job Overview
Company
Katalyst HealthCares & Life Sciences
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Job Description
Responsibilities:
Ownership of design change projects including scoping, assessment, and implementation.
Develop, update, and maintain Design History File and Design Input / Output documentation.
Update and maintain risk management files, such as the Hazard Analysis, Task Analysis, and Design FMEA.
Develop and execute Design Verification, Design Validation, and Usability protocols and reports to meet or exceed internal and external requirements.
Provide design quality support in the resolution of PIRs, CAPAs, and NCEPs.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Build Quality into all aspects of their work by maintaining compliance to all quality requirements.
Requirements: - Years with BS.
Degree must be clearly stated on resume.
Bachelor's degree in mechanical, electrical, or biomedical engineering, highly preferred.
Experience with design control, risk management, and medical device standards compliance.
Experience with corrective and preventive action.
Adaptable and effective collaborator in a team environment and in self-directed work.
Strong communication skills.
About Katalyst HealthCares & Life Sciences
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