Overview
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 and computer systems: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements management and traceability.
Responsibilities
- Ensure defendable software engineering and scientific analyses are employed on assigned projects.
- Provide software engineering services to new product development projects such as, use engineering, systems engineering, specification setting, defect resolution and essential design elements.
- Design experiments and conduct investigations to identify root cause of problems and implement effective corrective actions.
- Lead initiatives in process or product improvement areas.
- Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution.
- Develop QMS processes through cross-functional teams
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Qualifications
- Bachelors Degree (B.S.) 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 significant 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.
- Outstanding interpersonal and communication skills and ability to develop cross functional partnerships.
- 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.
- 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.
Company Description
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 over 60 years. With approximately 8,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.
Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We're the problem solvers and innovators that aren't afraid to take risks to transform the world of human health and well-being. We're all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.
Diversity and inclusion are fundamental to our core values at Waters Corporation. It is our responsibility to actively implement programs and practices to drive inclusive behavior and increase diversity across the organization. We are united by diversity and 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.