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Design Controls QA QE (Freelance)

Posted Dec 2, 2021
Project ID: PHILJP00024323
Eindhoven, Noord Brabant
40 hrs/week
6 months
Starts: Dec 15, 2021
Ends: Jun 14, 2022
Payrate range
51 - 71 €/hr


  • Enable remediation activities for products especially on the definition and implementation of design control activities
  • Review and Approval of designated project documentation in PDLM (Product Development Launch & Maintenance) programs
  • Perform a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement & harmonization, quality control and assurance.
  • Enable business in Design Reviews and review of Pre-market Product risk management activities/ documentation completeness
  • Initiate, stimulate, and support the implementation of process improvements 
  • Execution of process conformity checks, enabling the teams to close on findings and report the findings to upper management
  • Support and advise the organization in corrective and preventive actions
  • Participate in the maintenance, improvement and deployment of the Quality Management System
  • Translates regulations and standards to process artifacts for Quality Management System and deployment in the organization 
  • Participation in and verification of changes to DMR and release orders where Q&R involvement is needed.
  • Authors and completes relevant SW Quality Engineering documents with/ without direct supervision.
  • Provides SW quality engineering support, including assisting organizational units in addressing SW Quality engineering deficiencies.
  • Responsible for performing timely, detailed SW Quality engineering tasks like: reviewing software designs, test and other performance data, assisting with root cause analysis and SW Quality problem solving. 
  • Provides effective oversight of: the execution of the SW Quality Plan and all design related activities during the software lifecycle
  • Act as a single point of contact (person assigned to project team) responsible
    to ensure that software design quality related requirements/criteria are
    completed and meet SW Quality standards for every milestone for current programs and retrospectively for remediation programs

Qualifications and Know-How:

  • Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science , electronics, Electrical or information technology.
  • Around 6 to 8 Years of Professional Experience , with 2 to 3 Years in medical device domain
  • Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD/MDR, FDA-QSR, IEC62304)
  • Knowledge of (software) processes and procedures
  • Qualified Auditor of Quality Systems ( Preferable)
  • Good skills in reporting, both in writing and oral
  • Fluent speaker and writer in English
  • Project management knowledge and skills.
  • Knowledge of product creation and (software) development methods & tools
  • Experience in using problem solving tools
  • Knowledge of external regulations and standards relevant for our products 
  • Knowledge on Product Quality Engineering , metrics and KPI?s

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