Quality and Regulatory Specialist

Job Responsibilities:

Participates in the development and maintenance of comprehensive software quality documentation, including Software Requirement Specifications (SRS), ensuring they are accurate, up-to-date,

fully compliant with relevant standards and regulatory requirements throughout the software lifecycle, working under general supervision. Executes the assessment of software designs, including reviewing test and performance data,

to ensure they meet quality, safety, and regulatory standards, while identifying and addressing quality engineering deficiencies to embed quality within the design.

Conducts in-depth root cause analysis for software quality issues, employing problem-solving techniques to resolve deficiencies and improve software design processes, ensuring that quality is integral to the development process.

Guides validation of key software design inputs such as usability, reliability, performance, localizability, safety, privacy, and cost to ensure they meet customer and regulatory requirements, supporting the delivery of high-quality software products.

Ensures effective oversight of the execution of software quality plans and associated risk management activities throughout the software lifecycle, ensuring that all design-related activities are managed according to defined processes.

Utilizes post-market analytics and statistics to monitor software performance in the field, providing feedback to manufacturing, suppliers, and design teams, while initiating corrective actions or field actions when required to maintain software quality.

Participates in the development of comprehensive Software Quality Plans that cover all stages of the software lifecycle, from design through to post-market, supporting the design of these plans and ensuring adherence to quality and regulatory standards.

Possesses and applies working knowledge of relevant global regulations, requirements, and standards, ensuring that all quality activities and software design processes comply with applicable regulatory requirements, facilitating compliance throughout the software development lifecycle.

Provides guidance to meet schedules, resolve technical problems, and manage performance requirements, including mentoring on quality engineering practices, regulatory compliance, and QMS processes.

Reports key software quality metrics, ensuring these metrics are aligned with business objectives and regulatory expectations, while communicating quality-related performance indicators to relevant stakeholders.

Minimum required Education:

Bachelor's Degree in Computer Science, Computer Applications or equivalent Minimum required

Experience: Around 6 to 1o Years of Professional Experience , with at least 3 to 4 Years in medical device domain (software domain preferred)

Minimum required Certification: N/A Preferred

Preferred Experience: -Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDD/MDR, FDA-QSR 820/ QMSR, IEC62304, IEC62366) -

Working experience in Agile methodology enabling projects/ programs within regulatory compliance

Knowledge of (software) processes and procedures -Qualified Auditor of Quality Systems/ Experience in MDSAP audit as auditor/ auditee (Preferable)

Excellent communication skills

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 and metrics/ KPIs Preferred

Certification: CSQA/ISTQB certification Preferred

Skills: Design Quality Management Data Analysis & Interpretation Design for Quality (DFQ) Root Cause Analysis (RCA) CAPA Methodologies Regulatory Requirements Privacy, Safety and Security Risk Assessment Technical Documentation Continuous Improvement Software Development Life Cycle (SDLC) Product Quality and Reliability Defect Management Design Verification Planning Design Validation Planning Product Test Design