Design Controls QA QE (Freelance)

Responsibilities

• 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