Design Quality Engineer

Overview

This position will be responsible for concurrent quality engineering science activities associated with the consumables and lab automation product development business unit, on-market design change, risk management, quality systems and Waters requirements for columns, kits and chemistry products.

Primary responsibility will be to provide chemistry/scientific and product support in the following areas: design controls, risk management, change control, post market review, quality planning, continuous improvement, establishment of appropriate requirements management and traceability.

This is a Hybrid position based in Milford, MA

Responsibilities

DUTIES AND RESPONSIBILITIES

• Participate in new product development projects working as a member of multi-functional product development teams representing the Design Quality function. Work closely with R&D, Engineers, Scientists and Manufacturing on assigned projects by providing technical quality engineering/science/chromatography support. Ensure engineering and scientific analyses are employed and design history files align with company policies and applicable standards and regulations. Transfer knowledge of inherent product design risks and mitigating controls resulting from the design process to colleagues.
• Key work include but are not limited to performing previous product analysis on similar products and risk management activities. Supporting project team activities for requirements management, design reviews, design verification, design validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
• Facilitate Risk Management activities according to company policy, procedures and ISO 14971, including Risk Management Planning, Preliminary Hazard Analysis, Risk Analysis using FMEA tools (Design, User & Process FMEA), Risk Management Report and Risk Management File.
• Work with global Design Quality Assurance peers and Product Development partners to identify and develop improved or harmonized Product Development processes/systems and drive implementation within the relevant development areas.
• Monitor Projects, ECR's, Deviations and Complaints management Systems to identify product quality trends and translate this information into improved product designs. Facilitate and participate in Root Cause Analysis of identified product and process deficiencies initiating system corrective actions as required.
• Act as Quality signatory on Product Development work ensuring that company and departmental objectives are met.
• Work multi-functionally and within Waters Global Quality Assurance to ensure activities and potential improvement work is aligned and harmonized.
• Apply statistical methods and process/design excellence techniques to support development of V&V test plans and data evaluation.

• Minimum of a Bachelor's degree in Engineering or Science related function, or 3+ years of validated shown experience in a regulated Engineering/Science related function, or 1+ years of similar confirmed experience.
• Experience in the application of production and process controls including process validation, process control plans and statistical process control.
• Experience in product development of LC consumables such as LC Columns, SPE, sample prep kits, etc.
• Proven understanding of ISO9001, ISO 13485, 21 CFR Part 820, IVDD 98/79/EC, MDD 93/42/EEC, IVDR 2017/746/EU and MDR 2017/745/E.
• Proven understanding and experience with 21CFR820 Design Control, ISO62304, IEC62366-1 or equivalent is desired.
• Experience with Root Cause Analysis techniques e.g. 8D, 5 Whys, Cause and Effect Analysis and knowledge of continuous improvement techniques.
• Experience in Design for Six Sigma, Manufacturability, Service, Inspection is desired.

• Solid understanding of chemistry/method (LC/MS) instrument performance, use, customer experience, construction, and functionality and broad experience in LC/MS product evaluation and testing is desired.
• Experience with analytical tools & methods, including statistical tools such as Minitab is a plus.

• Good technical writing and oral communication skills are required to ensure succinct report generation, and effective communication with staff, peer groups and across organization.
• Ability to constructively challenge designs and engage in open conversations.
• Strong analytical skills with the ability to identify, analyze, and tackle problems with minimal direction and make decisions with confidence.
• Strong project management skills, consistent record to facilitate activities, balance and prioritize multiple ongoing projects/tasks, lead teams, contribute optimally 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 "contributed" to company.
• Be accountable for quality of their work, by adopting a "right first time" approach.
• Must be able to work independently and connect with all levels of the organization.
• Develop an environment that values diversity and inclusion.
• Computer literate, preferably with knowledge of software packages such as Word, Excel, and Power Point to for example, reports, presentations, analyze data, etc.