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Alchemy is currently partnering with a global technology firm who are looking to recruit a Design Quality Engineer ( DQE ) to be based onsite in Irvine, CA.
- Develops and conducts gap analysis and remediation of Design controls to Medtronic Quality Management System requirements.
- Demonstrated hands-on experience in Design Controls mandatory, including but not limited to Design Characterization, Verification and Validation studies, Aging Studies, Risk Assessment and Management, Design inputs and outputs, statistical analysis (including sampling plans).
- Develops and conducts gap analysis and remediation of DHF (Design History File) to external standards and regulations, including but not limited to ISO 14971, IEC 62366, ISO 13485, ISTA 2A/3A, EU MDR.
- Applies corrective measures that meet acceptable reliability and regulatory standards.
- Develops and conducts test methods, test method validations and statistical process control procedures (Variable/Attribute data analysis) for achieving required levels of product reliability.
- Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- Works independently under limited supervision to determine and develop approach to solutions.
- Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
- Degree in Mechanical, or Biomedical Engineering (or relevant course) with minimum 6 years of experience in Medical device industry.