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Senior Quality Engineer

Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science-Based Discipline
Travel : No
Relocation : No

Job Description :

Our Client is looking for a Sr. Quality Engineer to join their team.

Qualities of a Quality Engineer:

  • Developing and documenting the process of mixing, coating and manufacturing pharmaceutical products

  • Design, develop and commercialize New Pharma projects

  • Qualify, validate, and verify the process

  • Interpret FDA drug regulations and customer specifications

  • Determine in-process controls required to assure process/product meet CQA and customer quality requirements

  • Utilize effective CAPA and Root Cause Analysis tools during investigation of Customer Complaints, material review reports, incidents, and other applicable non-conformances

  • Support existing commercialized processes and improvement initiatives 

  • Customer Focused

  • Collaborative Team Player


Required Qualifications :

  • BS Engineering or science-based discipline and 5 yrs Quality Engineering experience, preferably in the Pharmaceutical industry supporting a R&D Team

  • Excellent Written Communication and Technical Report writing

  • Previous experience facilitating quality meetings between client and project team

  • Ability to navigate ambiguity and multiple points of view to facilitate effective solutions to development regulatory challenges

  • Demonstrated successful application of quality by design tools, including DOE, FMEA, ANOVA, Gage R&R, and basic/advanced SPC, and tools

  • Ability to read, interpret, apply and communicate technical information, including drawings, statistical data and specifications

  • Knowledge and ability to understand manufacturing processes

  • Ability to implement quality standards, procedures, specifications and corrective actions

  • Experience in Die Cutting and Bach Record Keeping

  • Knowledge of ISO 9001 and/or 13485, regulatory standards (cGMP, QSR) and Quality system standards, processes and procedures

  • Six-sigma black belt certification preferred

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