Quality Engineer Job in Raritan 08869, New Jersey US

Quality Engineer I

 

1.        PURPOSE:

 

Provide engineering support in the development and maintenance of company’s quality systems. Performs investigations relating to root cause of customer complaints, proposes and implements corrective and preventative actions as required.

 

 

2.        EDUCATION / EXPERIENCE REQUIRED:

 

Bachelor of Science degree in a technical field (for example, Electrical Engineer, Mechanical Engineering, Statistics, Computer Engineering, Chemical Engineering, Chemistry, Biology etc) or a Bachelor of Arts degree with at least 10 years experience in a quality or technical field

 

5 – 9 years experience with BS

3 – 7 years experience with MS

 

Required:

·         Able to read and understand electrical and mechanical schematics.

·         Strong integration skills to identify Manufacturing and Supplier related issues of Medical Device Capital Equipment.

·         Have working knowledge of Digital Multimeter, Data Capture, and other electronic instrumentation and tooling.

·         Have working knowledge of how to use measurement tools including calipers, force gauges, micrometers and other mechanical instrumentation and tooling.

·         Strong mechanical background to troubleshoot electro-mechanical systems.

·         Demonstrated ability to work effectively with cross-functional teams for complaint investigation, root cause analysis, identification and implementation of CAPAs.

·         Ability to effectively prioritize and manage multiple activities and responsibilities.

·         Has an understanding of statistics and how to utilize them in post-market surveillance and service activities.

·         Understands Failure Modes and Effects Analysis and Fault Tree Analysis

·         Experience in a Quality functional area with competency in Quality System Regulations.

·         Experience with the application of systemic and investigative tools (Pex, Six Sigma, SPC, and Pareto Charting) to evaluate product quality attributes and failure modes.

·         Broad based technical knowledge and skills in diverse areas of business a plus (Operations, RD, Field Service).

·         Understanding of basic office software tools including Excel, Word, Visio

·         Able to write and communicate clearly

Preferred:

·         Understands Human Factors and Health Hazard risks

·         Six Sigma Green Belt or Black Belt

·         Experience with FDA auditors

·         Certified Quality Auditor or Certified Quality Engineer

 

3.        KEY JOB RESPONSIBILITIES:

·         Under general supervision investigates customer complaints regarding product design, product manufacture, and product testing.

·         Reviews and critiques investigations of peers for sufficiency and thoroughness

·         Participates and leads projects that improve the complaint process and reduces overall customer issues.

·         Participates in design evaluations (FMEAs).

·         Participates in process evaluations (PFMEAs)

·         Participates in Human Factors evaluations (Health Hazards and System Risk)

·         Devises and implements methods and procedures for inspecting, testing and evaluating product.

·         Determines and implements solutions to customer issues.

·         Participates in the training of new and lower level quality engineers.

·         Provides imaginative, thorough and practical solutions to a wide range of difficult problems.

·         Erroneous decisions or recommendations or failure to achieve results might cause serious delays and considerable expenditure of resources.

·         Provide support during External and Internal Audits of the Customer Quality process


Please respond with a copy of your resume to garima@ustechsolutions.com