Quality Engineer

  • location: Durham, NC
  • type: Contract
  • salary: $32.47 - $47.85 per hour

job description

Quality Engineer

job summary:
A Quality Engineer is needed for a manufacturing company considered one of the world's leading innovators in materials science in the Durham, NC area. This position works closely with other functions within the organization (Manufacturing, R&D, Continuous Improvement, Quality, Engineering, Procurement, and Marketing) and is responsible for the quality of the product and process for the assigned product line(s).

 
location: Durham, North Carolina
job type: Contract
salary: $32.47 - 47.85 per hour
work hours: 8am to 5pm
education: Bachelors
 
responsibilities:
  • Provide product team support including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.
  • Quality help desk and customer complaint point of contact and problem resolution including Questionnaires, Certificates, and Customer Surveys etc.
  • Facilitate investigation of Failure Investigation Reports (FIR), Situation Analysis (SA) and Health Hazard Evaluation (HHE) with clear documentation of corrective actions.
  • Lead discussions on blocked stock and open notifications in Material Review Board (MRB).
  • Support Life Sciences Corporate (Tewksbury) with Customer Notification Letters from plant projects as needed.
  • Assist with the investigation of Corrective & Preventive Actions (CAPA), non-conforming product, and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.
  • Apply quality engineering practices and guidance to support project teams and manufacturing operations using Six Sigma tools, FMEA, CE Diagram, DOE, MSA, Validation Protocol development, review, approval and Control Plans.
  • Support Continuous Improvement activities and key plant projects.
  • Develop/Revise Quality Plans including: incoming, in-process and final inspection, and provide training to those affected by the plans.
  • Implement proven inspection and metrology improvements and associated training.
  • Review and approve Project Design History Files.
  • Create technical process documents that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
  • Serve as a resource for performing internal audits to ensure quality system compliance.
  • Able to react to change and perform other duties as assigned.
MINIMUM QUALIFICATIONS:

  • Bachelor's Degree
  • Minimum of 2 years of manufacturing quality engineering experience in a highly regulated industry (medical device industry preferred.)
Skills/Experience:

  • Working knowledge of databases, including Access, spreadsheet applications, Microsoft Project, Minitab and word processing, to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with product teams.
  • Ability to make decisions regarding product disposition and corrective and preventive action effectiveness. Comfortable in giving direction to accomplish assigned tasks.
  • Knowledge of manufacturing processes and relevant statistical methods for quality assurance, i.e., capable of Six-Sigma skills, certification preferred.
  • Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.
  • Proficiency in Minitab, Microsoft project, word processing, database, and spreadsheet applications.
  • Demonstrated technical writing skills.
  • Thorough knowledge of the regulatory industry requirements ISO13485, Quality Management Systems, Regulation CFR 21 part 820, GDP / cGMP
  • Six Sigma certification desired.
  • ASQ Certified Quality Engineer desired.
#LI-MR1

 
qualifications:
  • Experience level: Experienced
  • Minimum 2 years of experience
  • Education: Bachelors
 
skills:
  • Quality

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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    Quality Engineer

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  • date posted: 2/17/2021