Waters Corporation

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Senior Design Quality Engineer New Product Development

Senior Design Quality Engineer New Product Development

Req. # 
6300
Company Name 
Waters Division
Category 
Quality Assurance
Location 
US-MA-Milford
Type 
Regular Full-Time

More information about this job

Company Description

For over 50 years, Waters Corporation has developed innovative analytical science solutions to support customer discoveries, operations, performance, and regulatory compliance. Specifically, the company designs, manufactures, sells, and services high performance liquid chromatography, ultra performance liquid chromatography, and mass spectrometry technology systems and support products primarily in the United States, Europe, Japan, and Asia. Our innovations enable significant advancements within the pharmaceutical, life science, biochemical, industrial, food safety, environmental, academic and government industries. Waters is a publicly traded corporation (NYSE:WAT) with more than 6,500 employees and is represented in over 100 countries around the world.

 

 

Waters Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status. 

Overview

This position will be responsible for concurrent quality engineering activities associated with new product development, quality systems and risk management on diagnostic systems. Primary responsibility will be to handle quality engineering duties in the following areas: design controls, risk management, change control, post market review, quality planning, and establishment of appropriate requirements management and traceability.

Responsibilities

Design Controls/Quality System

  • Participate in new product development projects by providing quality engineering services to assigned projects. Ensure defendable engineering and scientific analyses are employed and design history files comply with company policies and governmental regulations. Key deliverables including, but not limited to product performance analysis on similar products, risk management, essential requirements checklist, design verification / validation, design transfer to manufacturing, documentation completion tracking, and product release authorization for distribution of product.
  • Conduct investigations to identify root cause of problems and implement effective corrective actions. Participate in internal audits and suppliers evaluations. Defines and establishes needed quality initiatives. Develop quality system procedures through cross-functional teams.

Engineering Drawings/Specifications

  • Review drawings to evaluate quality requirements, proper use of engineering, process and material specifications, and identification of key characteristics for inspection plans and methods. Recommend revisions to assure design requirements are specified in the appropriate detail and clarity to provide a successful design transfer. Review and approve engineering change requests. Review product verification and validation plans and approve reports.

 

Production and Process Controls

  • Assist manufacturing sites with the interpretation of quality requirements including verification/validation planning and execution, first production run requirements, and problem resolution. Develop control plans that identify inspection characteristics, gauging techniques, and sampling requirements. Work with manufacturing sites to resolve conflicts and recommends revisions as required.
  • Train and coach DQEs and Associate DQEs. Provide training and business process expertise within and outside the quality department. Provide support to other Global Quality projects as needed
  • Support the applicable site Quality System

Qualifications

 

 

  • Bachelors Degree (B.S.) in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university and a minimum of seven (7) years related experience.
  • Experience in the application of design controls and risk management in an IVD or Medical device industry.
  • Experience in product development with complex systems (mechanical, electrical, software, chemistry), including systems engineering and software design and development.
  • Experience in the application of production and process controls including process validation, process control plans and statistical process control.
  • 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.

 

 

Preferred:

 

  • Master’s degree (M.S.) in mechanical engineering, mechanical engineering technology, biomedical engineering (or other technical degree applicable to position being filled) or related discipline from an accredited university and a minimum of five (5) years related experience.
  • A quality engineering certification from the American Society for Quality, or other qualifying organization. Examples include the CQE, CRE, etc.
  • 5-8 years of experience in the medical device or IVD industry, knowledge of CFR 21 Part 820 (QSR), ISO 13485, CMDCAS, MDD 93/42, PAL, and other domestic and international regulations that may apply.
  • Experience in product system level evaluation & testing.

 

 

OTHER SKILLS and ABILITIES:

 

  • Ability to work effectively in a team environment and build strong working relationships.
  • Ability to constructively challenge designs and engage in transparent conversations.
  • Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence.
  • Superior communication skills, both oral and written and ability to develop cross functional partnerships.
  • Foster an environment that values diversity and inclusion.
  • 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.
  • Proficient with Microsoft Office (Word, Excel, PowerPoint)
  • Overnight travel (up to 15%) may be required.

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