SayPro
SayPro – QA Officer [Medical Devices] Full Time NEW – SayPro
SayPro, Oklahoma City, Oklahoma, United States
Job purpose
Provide support in upholding and driving quality excellence in production and final products (medical devices) to ensure they comply with local and international standards, including ISO 13485, lead on document control, validation support, audits, and risk assessments, while promoting a strong quality culture through training and proactive compliance monitoring
Main Responsibilities
Develop, review, and maintain Standard Operating Procedures (SOPs), Work Instructions, and validation/testing protocols. Oversee protocol execution to ensure data integrity, compliance, and traceability. Deliver online training sessions on Quality Management Systems (QMS), ISO 13485 standards, and internal SOPs. Manage document control, including version management, approvals, and access logs. Support and participate in internal audits, track non-conformances, and drive CAPA (Corrective and Preventive Actions) to closure. Conduct risk assessments (ISO 14971/FMEA) and guide cross-functional teams on appropriate risk mitigation and CAPA actions. Prepare and submit weekly QA reports covering KPIs, audit findings, deviations, and escalations of unresolved quality issues Requirements
Bachelor’s degree in Science, Biomedical Engineering, Pharmacy, Life Sciences, or a related field Minimum 4 years in QA/QC
within the medical device industry, including experience with ISO 13485, validation, SOP development, and lab instrument handling Conversant with quality assurance frameworks, standards, and best practices, especially within the medical equipment/devices industry Conversant with ISO 13485 QMS: Proven experience in internal audits, CAPA systems, validation, risk management, and document control Practical experience in compiling and submitting quality documentation for WHO prequalification Familiarity with QA requirements, product evaluations, and supplier audits in support of UNICEF procurement processes and frameworks Excellentwritten and verbal communication skills in English Self-driven, analytical, attention to detail, strong problem-solving skills Capable of working independently and collaboratively in a regulated, fast-paced environment
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Develop, review, and maintain Standard Operating Procedures (SOPs), Work Instructions, and validation/testing protocols. Oversee protocol execution to ensure data integrity, compliance, and traceability. Deliver online training sessions on Quality Management Systems (QMS), ISO 13485 standards, and internal SOPs. Manage document control, including version management, approvals, and access logs. Support and participate in internal audits, track non-conformances, and drive CAPA (Corrective and Preventive Actions) to closure. Conduct risk assessments (ISO 14971/FMEA) and guide cross-functional teams on appropriate risk mitigation and CAPA actions. Prepare and submit weekly QA reports covering KPIs, audit findings, deviations, and escalations of unresolved quality issues Requirements
Bachelor’s degree in Science, Biomedical Engineering, Pharmacy, Life Sciences, or a related field Minimum 4 years in QA/QC
within the medical device industry, including experience with ISO 13485, validation, SOP development, and lab instrument handling Conversant with quality assurance frameworks, standards, and best practices, especially within the medical equipment/devices industry Conversant with ISO 13485 QMS: Proven experience in internal audits, CAPA systems, validation, risk management, and document control Practical experience in compiling and submitting quality documentation for WHO prequalification Familiarity with QA requirements, product evaluations, and supplier audits in support of UNICEF procurement processes and frameworks Excellentwritten and verbal communication skills in English Self-driven, analytical, attention to detail, strong problem-solving skills Capable of working independently and collaboratively in a regulated, fast-paced environment
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