Software Quality Engineer

Waters Corporation   •  

Milford, MA

Industry: Professional, Scientific & Technical Services

  •  

Less than 5 years

Posted 49 days ago

Overview

Waters Corporation is currently seeking a Software Quality Engineer to join our organization.

This position will be responsible for concurrent software quality engineering activities associated with new product development, business / quality systems and risk management. Primary responsibility will be to handle quality engineering duties in the following areas of software development: design controls, risk management, change control, post market review, quality planning, and traceability.

Responsibilities

  • Support 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 - mentor/train 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 direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product compliance and product performance.
  • 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.
  • Ensure improvements are made in accordance with in accordance with the requirements of: ISO 9001; ISO 13485; 21 CFR parts 11 and 820.
  • Identify and produce meaningful metrics relating to area of responsibility. Trend and progress any required corrective actions
  • 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.

Qualifications

Experience

  • A Degree in computer science, systems engineering, or related degree (or other technical degree applicable to position being filled) or related discipline from an accredited university and a minimum of three (3) years related experience.
  • Strong working knowledge of software development life cycle models within a complex hardware/software development system.
  • Broad experience in the application of design controls and risk management in an IVD or Device industry.
  • Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
  • Experience representing their department during quality system audits.
  • Experience in the application of production and process controls including process validation, process control plans and statistical process control.
  • Good understanding of relevant regulatory requirements (e.g. IVDD, MDD, FDA) and standards (e.g. ISO 13485, 14971, BS EN 62304, 62366). Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820

Aptitude / Skills

  • Good technical writing and oral communication skills are required to ensure succinct report generation, and effective communication with staff, peer groups and across organisation.
  • Ability to constructively challenge designs and engage in transparent conversations.
  • Strong analytical skills with the ability to identify, analyze, and solve problems with minimal direction and make decisions with confidence.
  • Strong project management skills, proven ability to facilitate activities, balance and prioritize multiple ongoing projects/tasks, lead teams, contribute effectively in a team environment and build strong working relationships.
  • Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality to provide “added value” to company.
  • Be accountable for quality of their work, by adopting a “right first time” approach.
  • Must be able to work independently and communicate with all levels of the organisation.
  • Foster an environment that values diversity and inclusion.
  • Computer literate, preferably with knowledge of software packages such as Word, Excel, and PowerPoint to for example; reports, presentations, analyze data, etc.

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