Design Assurance Engineer
Design Assurance Engineer
Posted on :
31-07-2025
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1 Vacancy
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Job Description
Responsibilities:
- Ensure compliance with the Quality System and applicable GMP/ISO standards.
- Lead design assurance activities for electromechanical systems with microcontrollers PCBs and software components.
- Manage Design History Files (DHF) for new products.
- Define product requirements in collaboration with key stakeholders.
- Develop and execute test plans protocols and reports.
- Perform and support verification/validation testing including in vitro and animal studies.
- Conduct risk management activities including FMEA.
- Define supplier quality specifications and support sterilization method validation.
- Lead continuous improvement initiatives and support ECO reviews.
- Bachelors degree in engineering or related technical field.
- Strong understanding of quality system regulations (GMP ISO 13485).
- Experience with risk analysis verification/validation and electromechanical systems.
- Familiarity with regulatory requirements and design control processes.
Employment Type
Full-time
Key Skills
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