Quality Assurance Specialist for Medical Software

1 week ago

Lake Forest, Illinois, United States Precise Solutions Full time
Job Overview

At Precise Solutions, we are seeking exceptional professionals to join our organization and support our clients in the Life Sciences sector. We pride ourselves on being more than just a consulting firm; we offer competitive compensation packages that include attractive salaries, comprehensive benefits, health insurance, paid time off, and employer-sponsored 401k contributions.

Position: Software Quality Assurance Engineer - SaMD

Work Arrangement: Remote until further notice.

Compensation: $59.00 per hour, inclusive of paid time off, company 401k contributions, and health, dental, and vision insurance. Total annual compensation, including benefits, is approximately $173,000.00.

Note: Resumes with candidate photos will not be considered.

Role Description:

Tenure: Potential for extension beyond 6 months.

The primary focus of this role is to represent Quality Assurance within cross-functional teams dedicated to Software as a Medical Device (SaMD) and Digital Health Software development. You will be responsible for executing Quality System requirements to ensure that products are developed, tested, and released in accordance with global Medical Device Regulations. This includes authoring, reviewing, and approving project documentation related to the Software Development Life Cycle (SDLC) and design control requirements to meet Corporate, Division, FDA, and other regulatory standards.

Key Responsibilities:
  • Conduct QA activities pertaining to Software as a Medical Device (SaMD) and Digital Health Software Product Development.
  • Ensure adherence to the client’s software lifecycle policies and procedures.
  • Engage in design control and risk management activities aligned with the client’s Quality System.
  • Collaborate with technical teams to fulfill design control documentation requirements, including Risk Management and Traceability.
  • Assist in the preparation of regulatory submission documentation.
  • Identify gaps and opportunities for improvement within the Design History File and Risk Management, ensuring timely resolution.
  • Independently initiate assignments and actively lead development and process improvement teams, addressing quality issues proactively.
  • Monitor the effectiveness of processes and the quality of project work, proposing and implementing quality/process enhancements.
  • Draft and review policies, processes, and procedures related to the development of SaMD and Digital Health products in compliance with global regulations.
  • Apply knowledge of global regulations and corporate standards effectively.
  • Support and prepare for regulatory agency and internal audits.
Qualifications:
  • A Bachelor’s degree or equivalent in a relevant field such as sciences, engineering, or other technical/scientific disciplines.
  • A minimum of 5 years of experience in Quality Assurance, Development, or a healthcare-related field, with a preference for experience in Medical Devices, particularly Software Medical Devices.
  • Strong understanding of regulations and standards affecting software medical devices, including IEC 62304, 21 CFR, and EU MDR.
  • Experience in creating and maintaining Quality Management System (QMS) documents for medical device development.
  • Proven ability to coordinate and plan complex activities, with a knack for identifying and resolving intricate problems using technical and interpersonal skills.
  • Product development experience, including defining requirements and setting specifications for verification and validation, along with practical experience in design control and risk management.
  • Excellent oral and written communication skills to effectively convey quality positions and necessary actions to resolve issues.
  • Strong interpersonal, team, leadership, and negotiation skills to manage conflicting priorities.
  • Capable of presenting and justifying quality requirements clearly to management.

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