Software Quality Engineer (Medical Device)

Actalent

Minneapolis, MN

Contract

Senior

114k-156k

6 days ago

Job Description

About the Role

We are seeking a detail-oriented Software Quality Engineer who is adept at coaching staff and conducting comprehensive quality reviews of documents prior to submission. This role requires ensuring clarity of content, compliance with procedures, and a clear summary of conclusions and outcomes. The ideal candidate will be an expert in software and systems lifecycle controls for both waterfall and Agile methodologies, and proficient in system deliverables such as documenting requirements (User & System), software classification, risk assessment, and V&V Plans/Reports.

Key Responsibilities

Coach staff and provide detailed quality reviews of documents before submission.
Ensure clarity of content and compliance with procedures in documentation.
Summarize conclusions and outcomes clearly in documentation.
Expertly manage software and systems lifecycle controls for both waterfall and Agile methodologies.
Document requirements, software classification, and risk assessment effectively.
Prepare and review V&V Plans/Reports.
Manage PHI and PII compliantly.

Requirements

Proficiency in software quality assurance, validation, and software testing.
Expertise in technical writing.
Working knowledge of ISO/IEC standards.
Ability to identify required content for software requirements and report documents.

Nice to Have

Experience with software validation and documentation.
Knowledge of compliant management of PHI and PII.

Qualifications

Experience with software validation and documentation.

Benefits & Perks

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)

Working at Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. The company values precision and compliance, fostering a professional environment focused on high-quality deliverables.

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