Quality Compliance

Overview

Compliance Manage
Dublin City Centre
6-12 month contract

Primarily responsible for guiding Development teams through our quality system to ensure software is developed in compliance to internal procedures as well as the requirements of the FDA, ISO, and other regulatory bodies, which will include: IEC 62304:2006, ISO 13485, ISO 14971, FDA 21 CFR Part 11, FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001, AAMI TIR32, AAMI TIR36, AAMI SW87, AAMI TIR45, IEC 80001-1, BS EN 60601-1-2: 2007, CEI IEC 60812, IEC TR 80002-1, DS DS/EN 61508-6, ISO 60601-3rd Edition, FDA Mobile Medical Applications, EU Medical Device requirements – Council Directive, 93/42/EEC and FDA General Principles of Software Validation GPSV

  • You will own Design History Files for (DHF) for medical software development projects for Software as a Medical Devices (SaMD), legacy and new products
  • Serve as design controls (21 CFR 820.30) SME
  • In conjunction with the technical team, you will develop and organize design documentation including user needs, software requirements specifications, design specifications, verification/ validation plans and protocols, and risk management
  • Lead and perform risk management activities for software products
  • Represent the Quality function in all software development core teams
  • Lead design reviews, change assessment and configuration management with Product teams
  • You will represent design quality in meetings with regulators (like FDA), Customers, investors and other important stakeholders
  • Assist and support the Maintenance and compliance efforts of other QMS areas including:
  • Quality management Plans
  • CAPAs
  • Internal and Annual Audits (training provided if not a certified lead auditor)
  • Adherence to Quality Goals and metrics as per Management Plans
  • Updates to QMS documentation, as needed

Post Market Surveillance obligations and client reporting using problem Resolution for software development documentation

Documenting the Validation and Testing of software at unit and integrations and system stages

Processing change requests for projects

Continuously discover, evaluate, and implement new technologies to maximize development and test efficiency.

Software Engineering – Explore emerging technologies through R&D initiatives from time to time.

 

The Candidate:

Technical

  • Experience – A minimum of 5+ years’ experience working in a software field is essential, preferably with prior development experience as well. This is a senior position so you will need to be able to take ownership of projects.
  • BS/MS degree in Computer Science, Engineering or a related subject
  • Working knowledge of the mobile technology landscape, architectures, trends, and emerging technologies
  • Understand Medical Software Quality, test methods and tools
  • Solid understanding of the full mobile development life cycle
  • Candidate must be able to think in an Agile framework and know how to extract useful design outputs/ artifacts in collaboration with software development engineers. It is critical to understand how design controls is implemented in an Agile company.
  • ISTQB or ASQ CSQE or equivalent experience and certification is desirable

The Personal Competencies

  • Ability to communicate clearly and write detailed reports
  • Have a positive attitude and focus on client success
  • Ethical and honest in every part of the job
  • Work effectively in a team setting and collaborate openly with other engineers
  • Excellent organization and analytical skills combined with attention to detail. Ability to prioritize and plan effectively
  • Highly motivated with demonstrated ability to work independently with minimal supervision, but committed to a team oriented approach

 

Trish Lynch, Contracts Manager - Your e-Frontiers consultant for this job

Trish is a Contracts Manager with e-Frontiers. She has over 15 years recruitment experience in the areas of Software Development, Testing, Project Management and Business Analysis. She is has a BA Degree in Sociology and a Diploma in Business Studies from Michael Smurfits UCD. Trish has recruited across all industry sectors, Teleco, Consultancy, Pharma, e-Learning, Financial Services and Software.

Specialises in: Java, Project Managers, QA, Business Analysts, Architects