Senior Software Quality Assurance Engineer

Hi,

I hope you're doing well. I'm Naveen from DewSoftware, and we have an exciting open position that may interest you. Please share your updated resume, and I'll reach out to schedule a convenient time to connect.

Job Title: Senior Software Quality Assurance Engineer -Medical Device

Location: Minneapolis, MN-Onsite

Duration: Long-term Contract

W2 contract Role

Leading Medical Device Manufacturer.

A Senior Software Quality Assurance Engineer responsible for leading software quality, compliance, and documentation efforts across embedded, mobile, and cloud-connected medical devices. The role ensures adherence to FDA, IEC, and ISO standards, driving regulatory readiness and process excellence across software development teams.

🎯 Key Responsibilities

1. Software Quality Strategy

• Lead creation and execution of Software Quality Plans, Validation Strategies, and Test Protocols aligned with FDA 21 CFR Part 820 and IEC 62304.
• Oversee and approve SDLC artifacts — requirements, design specs, risk analyses, V&V reports.
• Manage cybersecurity validation and HIPAA compliance testing.

2. Regulatory & Compliance Oversight

• Ensure full compliance with IEC 62304, ISO 13485, ISO 14971, and FDA QSR.
• Support 510(k) documentation and maintain traceability matrices for regulatory submissions.

3. Process Governance

• Define and maintain SOPs, Work Instructions, and Quality Templates.
• Manage DHF, DMR, and DHR records and handle CAPAs and non-conformances.

4. Documentation Management

• Administer document and change control using Grand Avenue Software (DCNs, DCRs).
• Ensure robust version control and traceability for all deliverables.

5. Software Change Analysis

• Lead SCA to assess regulatory and validation impact of software changes.
• Update associated documentation, risk files, and test cases accordingly.

6. Audit & Inspection Readiness

• Prepare for FDA, ISO, and internal audits; ensure audit-ready documentation.
• Conduct internal quality reviews.

7. Tools & Automation

• Utilize Azure DevOps, Jama, DOORS, or Polarion for requirements and traceability.
• Support SBOM, SUoP validation, and DevOps-based quality tracking.

8. Training & Quality Culture

• Conduct SQA process training and promote a compliance-first culture across teams.

🧠 Required Qualifications

• 6–10 years in software quality for medical devices or regulated industries.
• Deep expertise in IEC 62304, ISO 13485, ISO 14971, FDA 21 CFR Part 820.
• Experience with Class II/III device regulatory submissions (510(k)).
• Skilled in automated testing (Selenium, Appium) and scripting (Python, Java).
• Familiarity with Jira, TestRail, Azure DevOps, or equivalents.
• Proven leadership in multi-project quality management and audit preparation.

💡 Preferred Qualifications

• Experience with Software as a Medical Device (SaMD) and connected health ecosystems.
• Knowledge of cybersecurity, HIPAA, and data integrity frameworks.
• ASQ certifications (CQA, CQE) or quality auditing credentials.
• Excellent communication and cross-functional leadership skills.