Software Quality Engineer

Innovation Business Process Document Control Resource Planning ISO/IEC Standards Software Validation Regulatory Compliance Constructive Feedback Artificial Intelligence Quality Management Systems Engineering Design Process Software Quality (SQA/SQC) Product Lifecycle Management Enterprise Resource Planning, We are seeking a Software Quality Engineer with expertise in authoring NonProduct Software Validation quality records for Quality Management Systems. The ideal candidate will ensure compliance with applicable regulations, standards, and corporate governing procedures, with a focus on systems such as Training, Document Control, PLM, and ERP., * Author NonProduct Software Validation quality records in accordance with regulations, standards, and corporate procedures.

• Act as a subject matter expert for 21 CFR Part 820, ISO standards, and 21 CFR Part 11/Annex 11.
• Evaluate quality records for compliance and deliver constructive feedback to authors.
• Coach coworkers on regulatory compliance and applicable governing procedures.
• Perform approver roles including Change Initiator, Quality Representative, Business Process Owner, and Technical System Owner.
• Manage multiple concurrent projects, ensuring all deliverables are completed and maintaining visibility into progress., Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools. Related Jobs Software Validation Engineer Actalent Minneapolis, MN*Remote Visionary Innovation Business Process Document Control Resource Planning ISO/IEC Standards Software Validation Regulatory Compliance Constructive Feedback Artificial Intelligence Quality Management Systems Engineering Design Process Software Quality (SQA/SQC) Product Lifecycle Management Enterprise Resource Planning Title 21 Of The Code Of Federal Regulations +0

Google IT Automation with Python Quality Engineer Actalent Saint Paul, MN*On-Site Auditing Visionary Operations Leadership Innovation Supply Chain

• Experience in software validation and quality assurance.
• Proficiency in authoring quality records for QMS NPSW.
• Expertise in regulatory standards such as 21 CFR Part 820 and ISO.
• Ability to evaluate and provide feedback on quality records.
• Experience in managing cross-functional teams.

Additional Skills & Qualifications

• Experience with systems like PLM (Product Lifecycle Management) and ERP (Engineering Resource Planning).
• Ability to coach and mentor coworkers on compliance.
• Capability to perform in various approver roles.

Work Environment

The work environment involves managing multiple projects and facilitating cross-functional teams. The role may require adapting to different systems and ensuring compliance with corporate procedures., Problem Solving Medical Devices Technical Writing Health Technology Electrophysiology Method Validation ISO 13485 Standard Process Validation Root Cause Analysis Process Improvement Statistical Analysis Validation Protocols Six Sigma Methodology New Product Development Manufacturing Processes Artificial Intelligence Manufacturing Operations Deviation Investigations Manufacturing Engineering Quality Management Systems Engineering Design Process Continuous Improvement Process Qualification Protocols (IQ/OQ/PQ) Corrective And Preventive Action (CAPA)

This is a Contract position based out of Minneapolis, MN. Pay and Benefits

The pay range for this position is $50.00 - $70.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• 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) Workplace Type

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. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.