Sustaining Systems Design Quality Engineer
Sustaining Systems Design Quality Engineer
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Salary Not Disclosed
1 Vacancy
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:
- 3-5 Years with BS. Degree must be clearly stated on resume.
- Bachelors 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.
Employment Type
Full-time
