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Software Quality Engineer

Job Summary:  The Software QA  Engineer leads the delivery of regulatory and quality solutions to enable client success.  Other locations will be considered if open to travel. 

Key Areas of Demonstrated Competence: 5 R&Q Knowledge Areas

Depending on the individual client assignment(s), the Software QA Engineer may perform the following essential duties:

  • Supports the development of the software development deliverables associated with IEC 62304 or Part 11 in a remediation situation.  
  • Supports the software design verification and design validation plans for products based on performance specifications and risk analysis.
  • Leads daily regulatory and quality hands-on support to clients with very little direct supervision of an experienced consultant
  • Leads in the drafting of worldwide regulatory strategies and worldwide regulatory submissions
  • Leads Quality System Development programs as well as Quality System improvement programs
  • Leads quality audits and audit preparation of clients
  • Leads design assurance activities: safety risk management, usability, design verification and design validation
  • Leads process validation and other related quality manufacturing tasks
  • Identifies supplier quality specifications and other supplier qualification activities
  • Leads supplier audits
  • Conducts  post-market surveillance activities including complaint/MDR handling, design history file remediation, and other remediation activities under minimal supervision
  • Leads recall activities as directed by an experienced consultant
  • Completes an effective independent review of deliverables as assigned.


Project Resource Responsibility

  • Responsible for completing work activities, as defined by the project lead, on schedule and in accordance with the allotted hours
  • Communicates project risks and issues to the project lead in a timely fashion


  • Bachelor’s Degree in Electrical Engineering, Computer Engineering or equivalent technical Degree; or equivalent combination of education and experience.  Advance degree preferred.
  • Working knowledge of FDA Quality System Regulations, EU Medical Device Directives and International Electrical Safety Standards required.
  • Understanding and Experience with ISO 13485, IEC 62304, and general principals of software validation.  
  • 2-5 years related work experience.
  • 2 years of experience in the medical device industry required
  • Consulting experience preferred


  • Advanced knowledge in two or more of the following areas is required:
  • Quality System Regulations (FDA, ISO13485, EU Medical Devices Directive, Canadian MDR)
  • Market Clearance and strategy (510K, EU Technical Files, Canadian licensing)
  • Design controls, DHF Development and related standards especially International Electrical Safety, Biocompatibility, and ISO10993 Software Development and Validation per EN 62304
  • Design Verification and Design Validation
  • Safety and risk management per ISO 14971
  • Usability per ISO 62366 and other Human Factors Standards
  • Knowledge of C and Visual Basic Languages strongly preferred.
  • Experience with C, C sharp or assembly-level code development, real time signal processing and I/O control.
  • Process Validation
  • Computer skills required –Microsoft Office applications; statistical data analysis
  • Expert report writing skills required
  • Must be willing to travel, up to 50%

Key Behaviors

Action-Oriented, Approachable, Building Effective Teams, Business Acumen, Career Ambition, Composure, Courage (Managerial), Customer Focus, Decision Quality, Informing, Integrity & Trust, Interpersonal Savvy, Planning



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