Principal Design Quality Engineer, Software

Waters   •  

Milford, MA

Industry: Professional, Scientific & Technical Services

  •  

8 - 10 years

Posted 38 days ago

Overview

Waters Corporation is currently seeking a Principal Design Quality Engineer, Software to join our company. 

 

In this role, the individual will join our Quality team in the function of Design Assurance to help contribute to the establishment, implementation and maintenance of the quality management system in support of the Software Design and Development for Product Software.  Specifically, the individual will help ensure the highest levels of software product quality and customer satisfaction while maintaining statutory and regulatory compliance for Software. 

 

This is a great opportunity for an individual to help grow our business and expand our next generation products/emerging technologies. 

Responsibilities

  • Assume a Subject Matter Expert (SME) 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 - 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 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.

Qualifications

 

  • Minimum of Bachelors Degree. Preferably within Computer Science, systems engineering or related Engineering fields of study 
  • Minimum 7 years’ experience supporting quality assurance activities within software development. Preferably within regulated industries 
  • Desired - Extensive experience in new product development focused on software / quality engineering related activities in a regulated environment (e.g. ISO 13485, ISO 62304, 21 CFR part 820). 
  • 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 and root cause analysis methods, design and process control activities, verification and validation testing methodologies to drive software product quality for new product development in an 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”. 
  • Strong coaching and mentoring skills, with exceptional interpersonal and communication abilities.
  • Excellent attention to detail. Ability to work on one’s own initiative. Demonstrate sound judgment/rationale. Excellent report writing and reviewing skills.

8285