Dew Software
Senior Software Quality Assurance Engineer
Dew Software, Minneapolis, Minnesota, United States, 55400
Senior Software Quality Assurance Engineer – Medical Device
Location:
Minneapolis, MN – Onsite Duration:
Long‑term Contract – W2
About the Role:
Lead software quality, compliance, and documentation for embedded, mobile, and cloud‑connected medical devices. Ensure adherence to FDA, IEC, and ISO standards and drive regulatory readiness across software development teams.
Responsibilities
Develop and execute Software Quality Plans, Validation Strategies, and Test Protocols aligned with FDA 21 CFR Part 820 and IEC 62304.
Approve SDLC artifacts – requirements, design specs, risk analyses, and V&V reports.
Manage cybersecurity validation and HIPAA compliance testing.
Ensure full compliance with IEC 62304, ISO 13485, ISO 14971, and FDA QSR, supporting 510(k) documentation and traceability matrices.
Define and maintain SOPs, Work Instructions, and Quality Templates; manage DHF, DMR, and DHR records; lead CAPAs and non‑conformances.
Administer document change control using Grand Avenue Software (DCNs, DCRs) and maintain version control.
Lead Software Change Analysis (SCA) to assess regulatory and validation impact of software changes.
Prepare for and support FDA, ISO, and internal audits; conduct internal quality reviews.
Utilize Azure DevOps, Jama, DOORS, or Polarion for requirements and traceability; support SBOM, SUoP validation, and DevOps‑based quality tracking.
Conduct SQA process training and foster a compliance‑first culture across teams.
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)).
Proficiency in automated testing (Selenium, Appium) and scripting (Python, Java).
Familiarity with Jira, TestRail, Azure DevOps, or equivalent.
Proven leadership in multi‑project quality management and audit preparation.
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 preferred.
Excellent communication and cross‑functional leadership skills.
Seniority Level:
Mid‑Senior
Employment Type:
Contract
Job Function:
Advertising
Industry:
Medical Equipment Manufacturing
#J-18808-Ljbffr
Minneapolis, MN – Onsite Duration:
Long‑term Contract – W2
About the Role:
Lead software quality, compliance, and documentation for embedded, mobile, and cloud‑connected medical devices. Ensure adherence to FDA, IEC, and ISO standards and drive regulatory readiness across software development teams.
Responsibilities
Develop and execute Software Quality Plans, Validation Strategies, and Test Protocols aligned with FDA 21 CFR Part 820 and IEC 62304.
Approve SDLC artifacts – requirements, design specs, risk analyses, and V&V reports.
Manage cybersecurity validation and HIPAA compliance testing.
Ensure full compliance with IEC 62304, ISO 13485, ISO 14971, and FDA QSR, supporting 510(k) documentation and traceability matrices.
Define and maintain SOPs, Work Instructions, and Quality Templates; manage DHF, DMR, and DHR records; lead CAPAs and non‑conformances.
Administer document change control using Grand Avenue Software (DCNs, DCRs) and maintain version control.
Lead Software Change Analysis (SCA) to assess regulatory and validation impact of software changes.
Prepare for and support FDA, ISO, and internal audits; conduct internal quality reviews.
Utilize Azure DevOps, Jama, DOORS, or Polarion for requirements and traceability; support SBOM, SUoP validation, and DevOps‑based quality tracking.
Conduct SQA process training and foster a compliance‑first culture across teams.
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)).
Proficiency in automated testing (Selenium, Appium) and scripting (Python, Java).
Familiarity with Jira, TestRail, Azure DevOps, or equivalent.
Proven leadership in multi‑project quality management and audit preparation.
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 preferred.
Excellent communication and cross‑functional leadership skills.
Seniority Level:
Mid‑Senior
Employment Type:
Contract
Job Function:
Advertising
Industry:
Medical Equipment Manufacturing
#J-18808-Ljbffr