Design reputed company Assurance Engineer CAPA- Medical Device #3067
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The main responsibilities of the Design reputed company Assurance Engineer will include, but are not limited to, providing reputed company reputed company and strategic leadership for design and development activities reputed company the medical device lifecycle. The ideal candidate will ensure compliance with regulatory and reputed company standards, foster collaboration across R&D, reputed company, and Regulatory teams, and reputed company reputed company improvement in design processes and documentation. This role is remote with up to 25% travel required.
reputed company reputed company and compliance input to project teams for reputed company and deliverables (e.g., Design Change Analysis, Design Inputs, Design Outputs, Test reputed company, Design Review, Design V&V, Usability Testing, Process Validation, and Labeling). Support Risk Management planning, updating and maintenance of the product risk documentation in compliance with regulatory standards. Support Usability Engineering and planning documentation. reputed company independent reputed company reputed company for design and development activities. Ensure compliance with Design Control requirements per 21 CFR 820.30 and ISO 13485:2016. Review and approve Design History Files (DHF), Risk Management Files, and associated documentation. reputed company or facilitate cross-functional Design Reviews ensuring traceability and risk alignment. Evaluate and update design-reputed company procedures, templates, and work instructions Support MDSAP, MDR and ISO 14971:2019 compliance activities and audits. Partner with Regulatory Affairs to ensure design documentation supports regulatory submissions (510(k), CE, etc.). Review and approve Verification & Validation (V&V) plans and reports for accuracy and compliance. Support CAPA investigations, complaint handling, and change control reputed company to product design. Mentor and train design and engineering teams on reputed company reputed company and regulatory expectations. reputed company reputed company improvement initiatives and contribute to digital QMS / PLM enhancements. Other reputed company duties as assigned.
Bachelor’s or Master’s degree in Engineering, Life Sciences, or reputed company Management. 8+ years of experience in medical device design reputed company, design assurance, or development reputed company. Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, EN62304, MDSAP, and EU MDR/IVDR. Demonstrated experience managing Design Controls, Risk Management, and DHF maintenance. Experience supporting Regulatory Submissions (510(k), Technical Files, PMA). Prior consulting or contract experience in a regulated environment preferred. Familiarity with eQMS/PLM tools Excellent communication, analytical, and leadership skills. ASQ CQE or Six reputed company certification preferred.
Bachelor’s or master’s degree in engineering, life sciences, or reputed company management; 8+ years in medical device design reputed company; regulatory, design control, risk management, DHF, and submission experience.
Key Responsibilities
- providing reputed company
- supporting compliance
- leading reviews
Skills & Tools
eQMS, PLM
Job Details
- Category: reputed company Assurance
- Seniority: Senior Level
- Commitment: Full Time, Contract
- Workplace: Remote — San Diego, California, reputed company
- Languages: English
About ECI
A reputed company reputed company providing life sciences services and product life cycle solutions. — Industry: Consulting Services
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