Staftonic LLC
Quality Assurance Engineer - Medical Device
Staftonic LLC, Minneapolis, Minnesota, United States, 55400
Quality Assurance Engineer - Medical Device
Long Term Project. Key Responsibilities Lead Software Quality and Compliance Activities: Develop, implement, and maintain Software Quality Plans (SQPs), Validation Master Plans (VMPs), and Test Strategies in compliance with IEC 62304, ISO 13485, and FDA 21 CFR Part 820. Regulatory and Documentation Support: Review, approve, and maintain SDLC documentation, including design, verification, validation, and release records. Support 510(k) submissions, ensuring all software documentation is complete, accurate, and compliant. Quality System Management: Oversee Standard Operating Procedures (SOPs), Corrective and Preventive Actions (CAPAs), and ensure proper maintenance of Design History Files (DHF) and Device Master Records (DMR). Change and Document Control: Manage Document Change Notices (DCNs), Document Change Requests (DCRs), and conduct Software Change Assessments (SCAs) to ensure traceability and compliance throughout the lifecycle. Audit and Inspection Readiness: Prepare and participate in internal and external quality audits, ensuring all deliverables, processes, and records meet compliance expectations. Drive continuous improvement initiatives within the Quality Management System (QMS). Tool Utilization and Traceability: Utilize tools such as Azure DevOps, Jira, TestRail, Jama, or Polarion for traceability matrix management, requirements mapping, and defect tracking to maintain end?to?end visibility across all quality deliverables. Automation and Test Oversight: Collaborate with development and test teams to integrate automated testing frameworks (e.g., Selenium, Appium) and support test scripting using Python or Java to improve verification efficiency and reliability.
Qualifications and Experience
Education: Bachelors or Masters degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical discipline. Experience: 610 years of hands?on experience in Software Quality Assurance within the medical device or other regulated industries (pharmaceutical, biotech, life sciences). Technical Knowledge: In?depth understanding of IEC 62304 (Software Lifecycle Processes), ISO 13485 (QMS for Medical Devices), ISO 14971 (Risk Management), and FDA 21 CFR Part 820. Proven experience supporting regulatory submissions (510(k), CE Mark, etc.) and audit preparation. Tool Proficiency: Expertise in requirements management, test traceability, and defect tracking tools such as Azure DevOps, Jira, Jama, TestRail, or Polarion. Automation & Scripting Skills: Familiarity with automated testing frameworks and scripting in Python, Java, or similar languages. Soft Skills: Strong analytical and documentation skills, attention to detail, and the ability to collaborate effectively in cross?functional teams.
Seniority Level
Mid?Senior level Employment Type
Contract Job Function
Medical Equipment Manufacturing Location
Minneapolis, MN #J-18808-Ljbffr
Long Term Project. Key Responsibilities Lead Software Quality and Compliance Activities: Develop, implement, and maintain Software Quality Plans (SQPs), Validation Master Plans (VMPs), and Test Strategies in compliance with IEC 62304, ISO 13485, and FDA 21 CFR Part 820. Regulatory and Documentation Support: Review, approve, and maintain SDLC documentation, including design, verification, validation, and release records. Support 510(k) submissions, ensuring all software documentation is complete, accurate, and compliant. Quality System Management: Oversee Standard Operating Procedures (SOPs), Corrective and Preventive Actions (CAPAs), and ensure proper maintenance of Design History Files (DHF) and Device Master Records (DMR). Change and Document Control: Manage Document Change Notices (DCNs), Document Change Requests (DCRs), and conduct Software Change Assessments (SCAs) to ensure traceability and compliance throughout the lifecycle. Audit and Inspection Readiness: Prepare and participate in internal and external quality audits, ensuring all deliverables, processes, and records meet compliance expectations. Drive continuous improvement initiatives within the Quality Management System (QMS). Tool Utilization and Traceability: Utilize tools such as Azure DevOps, Jira, TestRail, Jama, or Polarion for traceability matrix management, requirements mapping, and defect tracking to maintain end?to?end visibility across all quality deliverables. Automation and Test Oversight: Collaborate with development and test teams to integrate automated testing frameworks (e.g., Selenium, Appium) and support test scripting using Python or Java to improve verification efficiency and reliability.
Qualifications and Experience
Education: Bachelors or Masters degree in Software Engineering, Computer Science, Biomedical Engineering, or a related technical discipline. Experience: 610 years of hands?on experience in Software Quality Assurance within the medical device or other regulated industries (pharmaceutical, biotech, life sciences). Technical Knowledge: In?depth understanding of IEC 62304 (Software Lifecycle Processes), ISO 13485 (QMS for Medical Devices), ISO 14971 (Risk Management), and FDA 21 CFR Part 820. Proven experience supporting regulatory submissions (510(k), CE Mark, etc.) and audit preparation. Tool Proficiency: Expertise in requirements management, test traceability, and defect tracking tools such as Azure DevOps, Jira, Jama, TestRail, or Polarion. Automation & Scripting Skills: Familiarity with automated testing frameworks and scripting in Python, Java, or similar languages. Soft Skills: Strong analytical and documentation skills, attention to detail, and the ability to collaborate effectively in cross?functional teams.
Seniority Level
Mid?Senior level Employment Type
Contract Job Function
Medical Equipment Manufacturing Location
Minneapolis, MN #J-18808-Ljbffr