Principal Design Quality Engineer - Software
Personnel Outsourcing, companie de recrutare si leasing de personal, de 10 ani pe piata din Romania cu peste 500 de salariati temporari pusi la dispozitia clientilor nostrii cu doua branch-uri la nivel national ( Bucuresti / Brasov), o companie intr-o constanta dezvoltare in domeniul resurselor umane integrate.Cerinte
Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment.
Extensive knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to drive software product quality for new product development in a ISO 9001 environment.
Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality, wants to provide added value.
Working knowledge of Agile software development methodology.
Demonstrated capability to lead, manage and drive change through a multi-disciplinary, geographically distributed team.
Strong leadership, coaching and mentoring skills.
Exceptional interpersonal and communication skills.
Excellent attention to detail.
Ability to work on ones own initiative.
Assume a Subject Matter Expert (SME) role on Product Software development process activities and related workflows in relation to regulatory compliance, provide solution-based problem resolution
Act as Quality specialist in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements.
Provide interpretation and guidance on industry best practice Software Development Life Cycle (SDLC) methodologies - mentortrain personnel involved in software development in respective to Best Practices.
Evaluate the acceptability of products for release, ensuring customer requirements specifications and internal Waters policies and procedures are met.
Provide leadership and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance.
Actively participate in andor facilitate the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verificationvalidation etc.) including software risk management, maintenance, configuration management and problem resolution.
Work cross functionally and within Waters Global Quality Assurance to ensure activities and potential improvement work is aligned and harmonized.
The following criteria are desirable, but are not essential since training will be provided for you:
Knowledge of software product design and execution of processes compliant to ISO 13485 and ISO 62304
Experience in medical device SDLC
Proven knowledge of design and execution of processes compliant to ISO 14971, ISO 62366, and 21 CFR 820