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Job

Design Quality Engineer

  • Job ref:

    12290

  • Location:

    Wallingford, United States

  • Sector:

    Mechanical Engineers

  • Contact:

    Dan Dubay

  • Published:

    4 months ago

  • Consultant:

    #

Job Description

Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.

We are currently seeking a R&D Engineer in Wallingford, CT.

 

Position Summary and Special Duties:

As a R&D Quality Engineer your day to day duties will consist of and may not be limited to:

The Design Quality Engineer supports the qualification and validation of new products and product modifications, new equipment builds and modifications to existing equipment for the purpose of ensuring manufacturing goals of producing quality products, efficiently and repeatedly are met.  The Design Quality Engineer must apply part 21 CFR 820 guidance, cGMP and applicable ISO standards during design & development and verification & validation activities. This position closely collaborates with the Engineering, Manufacturing, Manufacturing Engineering, Purchasing and Quality Control departments.

Key Responsibilities:

  • Support Engineering in creating design & development documentation for new/modified products, equipment, and systems.
  • Responsible for product, equipment, and process risk assessments, FMEAs, fault-tree analysis, risk management plans.
  • Creates requirement specification documents for manufacturing equipment and systems.
  • Creates and executes equipment and system qualification and validation protocols.
  • Collaborates with other quality engineers and design staff to determine best validation practices.
  • Recommends design or test methods and statistical sampling plans for achieving required levels of product and process reliability.
  • Compiles and analyzes performance reports and process control statistics; investigates and analyzes relevant variables potentially affecting product and processes.
  •  Brainstorms new and innovative ways to increase production efficiency.
  • Communicates clearly and effectively with others.
  •  Translates technical engineering language to layman’s terms for the purposes of presentations.
  •  Demonstrates ability to use measurement tools and machinery.
  • Follows company policies and practices as outlined in the Handbook, SOPs and SWIs and as well as follows guidelines regarding safety as outlined in the safety program and in accordance with the job function.
  • Support internal and external quality auditing activities.
  • Other duties as assigned.

Qualifications

Education and Experience:

  • A Bachelor’s degree in Mechanical, Electrical or Computer Engineering/Technology or related field.
  • 3 – 5 years Engineering or Quality experience working in the quality, engineering or manufacturing departments companies producing In Vitro Diagnostics (IVDs), Medical Devices, or Pharmaceutical products.
  • Demonstrated knowledge of design & development concepts, verification & validation concepts, processes, scale-up, transfer, problem-solving, trouble-shooting, and experimental design.
  • Technical excellence specific to equipment automation and process validation.
  • Must have strong communication skills, both verbal and in writing and possess a working knowledge of analytical and process equipment, quality control systems and statistical software.
  • Must have strong organizational skills.
  • The ability to work in a collaborative way as part of a team is a must.
  • Basic mechanical aptitude and a good working knowledge of mechanical and optical manufacturing equipment is desired.
  • Working knowledge of ISO 13485 and/or ISO 9001.
  • Proficient in Microsoft Office.

 

DETAILS:

  • Duration: Direct Hire
  • Location: Wallingford, CT
  • Salary:  Open depending on experience
  • Benefits: yes

 

Qualified candidates are encouraged to apply immediately!

Please include a clean copy of your resume and salary expectations and any references.

 

Submit resumes to: dan.dubay@lighthouseprofessional.com