Senior Design Quality Engineer, Software
Waters Division
Brasov, RO
5 zile în urmă

Overview

Waters is currently seeking a Senior Design Quality Engineer, Software to support and enable delivery of the next generation software product roadmap by evaluation and monitoring of software design and development activities.

This is a permanent position.

In this position, you join our Design Quality team supporting the development of specialist measurement and scientific analysis software, plus provide input into continual improvement of processes and working practices.

This is a great opportunity for a diligent and innovative individual to apply their expertise in making a real difference to the company and expanding our next generation products & emerging technologies.

Role Specific

  • Actively participate in and / or facilitate the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verification / validation etc.
  • including software risk management, maintenance, configuration management and problem resolution.

  • 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.
  • Provide guidance on Product Software development process activities and related workflows in relation to regulatory compliance, provide solution-based’ problem resolution.
  • Evaluate the acceptability of products for release, ensuring customer requirements / specifications and internal Waters policies and procedures are met.
  • Participate in assigned reviews related to software design and development, including design, project, business and governance.
  • Act as subject matter expert in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate ISO 9001, ISO 62304, ISO 62366, ISO 14971 and ISO 13485.
  • System Management

  • Review and update working practices and associated documentation to ensure conformity to Waters and regulatory requirements.
  • Identify new, or changes to existing, processes and systems to improve effectivity and efficiency of the Quality system in accordance with the requirements of : ISO 9001;
  • ISO 13485; 21 CFR parts 11 and 820, ISO 62304, ISO 62366, ISO 14971.

    Other

  • Work cross functionally and within Waters Global Quality Assurance to ensure activities and potential improvement work is aligned and harmonized.
  • Proactively escalate issues and risks appropriately through appropriate channels to Management.
  • Identify and produce metrics relating to software design and development, trend and propose corrective actions.
  • To undertake continuous improvement activities with aim to increase out of box quality to Waters customers.
  • Individual

  • Maintain the effectiveness of the Quality system at the sites via adherence to applicable policies and procedures.
  • Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR.
  • Adhere to Environmental, Health and Safety policies and procedures.
  • Education

  • Minimum of Bachelors degree BSc , Computer Science, systems engineering or related Engineering degree preferred OR extensive proven experience within a regulated occupational environment.
  • Desired - ISO 9001 internal auditor certification.
  • Experience

  • Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment.
  • Advanced 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.
  • Desired - Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment.
  • Desired - Previous experience of executing quality assurance activities supporting software development in a regulated environment ISO 9001, ISO 13485, ISO 62304.
  • Experience of working with Agile’ methodologies.
  • Aptitude

  • 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 .

  • Exceptional interpersonal skills using written and oral communication are required, for example to ensure succinct report generation, effective communication with stakeholders, peer groups etc. across organization.
  • Excellent attention to detail and reviewing skills.
  • Demonstrate sound judgment / rationale.
  • Must be able to work on one’s own initiative and independently.
  • Ability to work as an integral member of a cross functional team, with remote members.
  • Ability to travel (domestic or international).
  • Experience of working with onshore and offshore development teams.
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