Quality Engineer

Our client is a mission driven company whose products have a significant impact on human health world wide.

This role supports manufacturing operations, provides quality guidance, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.

Day to Day Responsibilities: •  support product team including, Material Review Board (MRB), customer complaint activities, statistical analysis, validation support, inspection plans, metrology, quality metrics and report functions.

• Facilitate investigations, 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).

• Assist with the investigation of Corrective & Preventive Actions (CAPA), notifications and customer complaints, providing solutions where possible. Communicate customer feedback to Quality Systems group.

• Works with functional groups to ensure changes proposed through the change management program have the proper technical review and that there is a risk assessment of requested changes

Required Education:

  • Bachelor’s degree in science, engineer or technical field, preferred.


  •  Manufacturing quality engineering experience in a highly regulated industry (medical device industry preferred.)

Required Skills:

  • Capable of the integration and application of user aimed manufacturing process documentation while meeting business and regulatory requirements.
  • Demonstrated technical writing skills.
  • 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.
  • Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
  • Good understanding of Continuous Improvement Methodologies, including lean, six sigma, statistical applications and validation.

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