Katalyst Healthcares and Life Sciences
Sustaining Systems Design Quality Engineer
Katalyst Healthcares and Life Sciences, Maple Grove
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.
- pply 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.
- 3-5 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.
- daptable and effective collaborator in a team environment and in self-directed work.
- Strong communication skills.