Job Description

Responsibilities:

• As a Subject Matter Expert (SME) for the software development process, provide "solution-based" advice to development teams
• As a Software Quality Assurance specialist, ensure conformance to applicable regulatory requirements
• Provide interpretation and guidance on industry best practice Software Development Life Cycle (SDLC) methodologies
• Evaluate the acceptability of products for release, ensuring customer requirements / specifications and internal Waters policies and procedures are met
• Provide leadership and direction on teams' quality activities in respect of design control deliverables, particularly those relating to product compliance and performance
• Actively participate in the development, review, and approval of design deliverables (planning, requirements, architecture, risk management, verification/validation, problem resolution, etc.)

Qualifications:

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.
• Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment.
• 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.

Required Knowledge, Skills, and Abilities

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.