Medical Device Engineer
Medical Device Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Develop implement and maintain software quality assurance processes for non-product software used in medical device development.
- Ensure adherence to regulatory standards (FDA ISO 13485 IEC 62304) and industry best practices for non-product software.
- Support audits and inspections by regulatory bodies ensuring that non-product software systems comply with quality and documentation standards.
- Ensure computerized systems are appropriately validated Assessment of applicability & criticality of GxP and 21 CFR Part 11.
- Creation and review of validation deliverables including but not limited to
- Requirement Specifications (User Functional.)
- Plan Qualification Protocol (Installation Operational Performance.)
- Reports (Summary Exception) of protocol execution Traceability Matrix.
- Periodic Reviews.
- System Retirement/Decommissioning.
- Execution of Dry/Test protocol run.
- Conduct Periodic Reviews to determine if the system is in a validated state and take appropriate actions.
- Perform System Retirement/Decommissioning of systems not in business.
- Work closely with software development and IT teams to establish best practices for quality and compliance.
- Provide expertise and guidance on quality assurance processes for non-product software to ensure robust software management.
- Drive continuous improvement initiatives in software development processes ensuring alignment with the companys quality management system.
Requirements:
- A Minimum bachelors degree in engineering Science or related technical field.
- Minimum of 4-5 years of experience in software quality assurance or software validation preferably within the medical device industry.
- Strong understanding of quality standards and regulatory requirements (e.g. FDA 21 CFR Part 820 ISO 13485 IEC 62304.)
- Experience with non-product software validation including tools for development testing and maintenance.
- Good knowledge and experience of CSV activities but not limited to.
- GxP and 21 CFR Part 11 applicability/criticality assessment.
- Identification Preparation and Review of validation deliverables such as Requirements Plan Protocols Test specifications Reports Traceability Matrix etc.
- Execution of Dry/Test protocols Conduct Periodic Reviews of systems.
- Perform System Retirement of systems that are not in business.
- Understanding of Medical Device Quality and Compliance.
- Good knowledge of GxP GAMP and 21CFR Part 11 guidelines.
- Working experience in Product Lifecycle Management (PLM) tool.
- Sound knowledge of computer system development lifecycles.
- Knowledge of JIRA JAMA software and test automation is a plus.
- Key Words to search in Resume Computer System Validation 21 CFR Part 11 GxP FDA 21 CFR Part 11 ISO 13485 IEC 62304.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
