Job Summary

Quality Engineer

  • Location:
    Danbury, Connecticut
  • Job reference:
    US_EN_3_107684_322145
  • Category:
    Quality
  • Contract Type:
    Contract/Temporary

Quality Engineer

The Quality Engineer will plan and coordinate quality programs and activities to ensure the quality and reliability of products. Assure the timely, accurate evaluation of product performance and compliance to safety and regulatory requirements prior to manufacturing and market release. Develop, execute and/or monitor quality plans and quality engineering tasks, as well as, manufacturing process validations and controls to ensure compliance with established requirements and regulatory expectations. Provide support for released products, and reliability recommend corrective actions, and plan for continuous improvements.

Responsibilities
• Represent Quality in product development teams/projects. Work with Project Engineers or QA Manager to develop & execute plans (quality plan, risk management plan) and requirements (safety, functionality, regulatory, usability) to ensure provisions for quality are addressed and resolved prior to release.

• Coordinate with the development of essential design control deliverables including, but not limited to product performance analysis on similar products, essential requirements checklist, design verification, design validation, design reviews, phase reviews, and product release authorization for distribution of product.

• Work closely with Product Development, the project team, or QA Manager to develop appropriate verifications, validations, and qualifications, for both new design and changes to released product.

• Review design inputs (specifications) and design outputs (reports, prints, etc.) to assure that appropriate design requirements are specified and to evaluate / confirm quality requirements prior to successful design transfer.

• Review, approve and develop product verification plans and respective test methods.

• Participate in process to review and approve engineering change requests.

• Work with Manufacturing to coordinate, and monitor production processes to ensure compliance to ISO 9001, ISO 13485, and other applicable regulatory requirements and to ensure that safe and effective products are produced.

• Provide validation support by applying manufacturing quality tools including, but not limited to: FMEA, DFMEA, PFMEA, IQ, OQ, PQ, control plans, process verification / validation plans, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.

• Lead and/or Participate in complaint investigations, failure analysis of returned products, and issues resulting in a stop ship/stop production; document findings, provide reports and analysis.

• Compile and institute quality metrics to trend, recommend, and implement corrective actions and appropriate follow-up, when necessary.

Required:

Bachelors Degree in Engineering, Electrical, Mechanical, Industrial, Biotechnology, Engineering Technology or equivalent
Ability to read, analyze, and interpret technical procedures and regulations; Ability to write technical reports, business correspondence, technical procedures, as well as, administrative procedures; Ability to present proposals, data, and issues to personnel at all levels;
Ability to provide solutions to difficult technical issues associated with specific projects.
Ability to determine and develop technical solutions to a wide range of difficult problems.


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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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