Quality Engineer

Farmingdale, NJ

Post Date: 05/07/2018 Job ID: 21242 Industry: Manufacturing Pay Rate: $25 - $29 HR

Job Description:

Our industry leading medical device design and manufacturing client has an immediate opening for an experienced Quality Engineer.

 Essential Job Functions: 

  • Follows all Quality System requirements and company procedures ensuring regulatory requirements are met in an ethical manner
  • Meets commitments on time with accuracy and attention to detail
  • Maintains current knowledge base of existing and emerging regulations, standards, or guidance documents.
  • Provide interpretive assistance, to all departments, regarding these documents
  • Participate in multidisciplinary teams to implement root-cause analysis, corrective and preventive action, and proof of effectiveness as quality issues are identified
  • Design, execute, and document gage R&R studies
  • Support training on Manufacturing and Quality System documents
  • Quality Representative for Material Review Board (NMR)
  • Conduct and follow up of SCAR process (SCAR issuance, Supplier notification, SCAR approval and effectiveness review)
  • Develop validation and/or verification protocols; execute validations/verifications and report on the conclusions to support new product development or process improvements
  • Release documents via the change control process as necessary. Train others where required
  • Support, investigate, determine root cause and respond to customer complaints and customer issued SCARs
  • Quality Representative for process and software validations (may require writing, reviewing, executing, analyzing and/or reporting on test protocols)
  • Prepare quality related deliverables in a timely manner
  • Prepare and execute Engineering studies as needed
  • Participate in CAPA root cause investigation and actions implementation.
  • Implement ongoing quality improvement processes working with cross functional teams
  • Acts as a consultant for areas related to his/her expertise.
  • Performs other related duties as assigned by management

 

Ideal Candidate Will Possess The Following: 

  • Must have three (3) years experience with a focus on equipment validation, calibration, and maintenance
  • A Bachelor's degree in engineering or related discipline is required; it may substitute for some of the years of required experience and knowledge
  • Experienced with Microsoft Windows, Outlook, Word, Excel, Microsoft Project, etc. is required
  • Basic knowledge of ISO 13485:2016 and FDA QSR
  • Strong root-cause investigator and problem solver within a manufacturing environment.
  • Mechanical aptitude with manufacturing experience
  • Well-developed written and verbal communication skills. Ability to write and comprehend instructions, short correspondence, and memos 
  • Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form
  • Well versed in data management and graphical presentation of data
  • Ability to generate reports using data analysis, SPC analysis/tools, and effectively communicate findings/proposals to various users in the organization 

 

Job Type:  3 to 6 months temp

Salary:   $25 - $29 / HR

 

Broad Waverly


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