Waters Corporation · 11 hours ago
Sr. Design Quality Engineer
Milford, MA
Full-time
Onsite
Senior Level
5+ years expWaters Corporation is a global leader in analytical instruments and technologies, and they are seeking a Senior Design Quality Engineer. The role involves providing quality leadership and support in quality system methodologies for product development within the chemistry business unit, ensuring compliance with quality standards throughout the development life cycle.
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Responsibilities
Participating or leading in design and development planning; quality planning; supporting development of design requirements specification; Design History File management, design transfer activities, change management and design reviews
Developing risk management documentation
Supporting development of design verification and design validation documentation
Supporting test method development and validations
Ensures company policies, procedures, practices and facilities are in compliance with all applicable company policies and procedures
Lead/support internal investigations, implementing corrective and preventive actions
Serving as a quality representative on one or more project teams engaged in product development activities
Ensuring each project is developed and released meeting customer expectations, regulatory requirements including 21CFR820, ISO 13485, ISO 14971, MDD
Qualification
Required
Bachelors Degree (B.S.) in chemistry, biology or related science/technical field, or related experience and a minimum of three (5) years or qualified related experience
Good understanding of chromatography and column products and their applications
Strong working knowledge of development life cycle models
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). Previous experience of working in a quality system regulated environment to ISO 13485 and/or 21 CFR 820
Ability to work effectively in a team-oriented cross-functional environment and build strong working relationships
Ability to constructively challenge concerns and engage in transparent conversations
Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence
Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills)
High degree of initiative and self motivation. Strong analytical skills and the ability to solve problems through analytical reasoning
Company
Waters Corporation
Waters Corporation is a global leader in analytical instruments, separations technologies, and software, serving the life, materials, food, and environmental sciences for over 65 years.
5001-10000 employees
H1B Sponsorship
Waters Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (30)
2023 (26)
2022 (13)
2021 (23)
2020 (15)
Funding
Current Stage
Public CompanyTotal Funding
$6MKey Investors
IDA Ireland
2022-10-07Grant· $6M
1995-11-24IPO
1994-08-01Private Equity
Leadership Team
Udit Batra
President and Chief Executive Officer
Recent News
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2026-01-20
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