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.
- 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.
- 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.