Design Quality Engineer
Design Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
Design Verification Support:
- Review and support design verification protocols and test reports.
- Ensure compliance with internal design verification design control equipment control and risk management procedures.
- Assist cross-functional teams to complete design verification activities on time.
- Guide and support issue management including opening processing and closure per internal processes.
- Support review and release of internal software tool validations.
Quality Systems Support:
- Handle ad-hoc quality needs as they arise.
- Ensure compliance with Good Documentation Practice (GDP).
- Review investigations corrections and CAPA/non-conformance activities.
- Support design control deliverables and phase closure readiness.
Risk Management:
- Help prepare for internal risk management reviews during design verification.
- Support evaluations and updates of internal risk management documentation.
Process Improvement:
- Participate in process improvement initiatives within the team.
Requirements:
- Strong understanding of FDA regulations for design control and verification and risk management.
- Knowledge of ISO 14971 and IEC 62304.
- Experience with computerized system validations.
- Applied statistical analysis experience.
- Excellent cross-functional collaboration and documentation skills.
- Familiarity with JAMA Jira Confluence and Slack.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
