Principal Design Quality Engineer - Software at Waters, Wilmslow, £Contract Rate

  • Contract Spy
  • Wilmslow SK9, UK
  • Sep 08, 2020
Duration not stated

Contract Description

Waters is currently seeking a Contract - Principal Design Quality Engineer, Software to support the delivery and full lifecycle management of software.

 

In this principle Design Assurance role, you join our Quality team supporting the development of specialist measurement and scientific analysis software.

 

In this position, you would evaluate and monitor product software design and development activities to ensure conformity to regulatory requirements and 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.

 

  • 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 including as appropriate ISO 62304, ISO 62366, ISO 14971 and ISO 13485.
  • 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 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 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.
  • Act as mentor to software design quality personnel.
  • 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.

General

  • Review and update working practices and associated documentation to ensure conformity to regulatory requirements.
  • To undertake continuous improvement activities with aim to increase out of box quality to Waters customers.
  • Complete Quality System related actions in a timely manner according to procedures e.g. CAPA, NCR [deviation, material faults, internal audit, external audit]
  • Adhere to Environmental, Health and Safety policies and procedures. Maintain an appropriate environment for the occupational health of employees.
  • Responsible for maintaining the effectiveness of the Quality system[s] via adherence to applicable policies and procedures
  • 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.

 

  • 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”.
  • Minimum of Bachelors degree [BSc], Computer Science, systems engineering or related Engineering degree preferred.
  • Desired - Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment.
  • Desired - Previous Senior Management experience of leading quality assurance activities supporting software development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.
  • Strong leadership, coaching and mentoring skills.
  • Exceptional interpersonal and communication skills. Excellent attention to detail. Ability to work on one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills. Change Agent – drives continuous improvement / compliance to regulations.
  • Ability to work as an integral member of a cross functional team, with remote members.
  • Experience of working with onshore and offshore development teams.
  • Experience of working with ‘Agile’ methodologies.

 

 

Waters Corporation (NYSE: WAT), the world 's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials and food sciences for 60 years. With approximately 7,000 employees worldwide, Waters operates directly in 31 countries, including 15 manufacturing facilities, and with products available in more than 100 countries.

 

Waters Corporation 's businesses include Waters, TA Instruments, VICAM, ERA, and Nonlinear Dynamics.

 

Waters creates business advantages for laboratory-dependent organizations by delivering ultra performance liquid chromatography (UPLC), high-performance liquid chromatography (HPLC), chromatography columns and chemistry products, mass spectrometry systems, laboratory informatics solutions, and comprehensive service programs to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.

 

 

 

Diversity and inclusion are fundamental to our core values at Waters Corporation. Celebrating diversity is important to us. We thrive on it for the benefit of our employees, our products, our customers and our community. Waters is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or protected Veteran status.