Sustaining Engineer
23 hours ago
12 Month Contract (May extend or convert to permanent)
$38/hour W2
Must Have Requirements:
- Degree in Engineering or Computing Field.
- Medical Device Industry experience and regulated work environment experience.
- Strong understanding and experience in design controls, failure investigation (leading an investigation).
- Ability to clearly communicate with diverse teams, including Engineering, Manufacturing, Regulatory, and Quality colleagues.
- Strong written skills for documenting changes, updates to risk files, and communication with leadership.
- Multidisciplinary assessment of complaints and problem-solving.
- Knowledge of CAPA processes and GDP.
- Familiarity with Excel for data analysis.
Day to Day Responsibilities:
- Complete product and manufacturing process changes, including documentation and risk file updates to ensure there is no adverse impact to the patient/user and product design integrity is maintained
- Implement change projects according to internal procedures, supervise progress, and communicate status to group leadership
- Communicate with Engineering, Manufacturing, Regulatory, and Quality colleagues
- Establish experimental protocols, conduct experiments, analyze results
- Support technical execution of Design History File (DHF) updates
- Establish and maintain relationships with Manufactuing site colleagues
- Support Manufacturing and Quality Assurance in the disposition of Non-Conforming Reports and the qualification of material/processes changes
- Establish and review specifications/requirements for components, products and processes
- Support CAPA investigations
- Ensures product conforms to current relevant international standards
- Support multi-functional assessment of complaint record
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thousand oaks, United States Planet Pharma Full time12 Month Contract (May extend or convert to permanent) $38/hour W2 Must Have Requirements: Degree in Engineering or Computing Field. Medical Device Industry experience and regulated work environment experience. Strong understanding and experience in design controls, failure investigation (leading an investigation). Ability to clearly communicate with diverse...
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