Tennessee - Direct Hire - Quality Engineer

Morristown, Tennessee
Quality Engineer

Bachelor’s degree (in Engineering, Science, or related) + 3+yrs experience in engineering + process validation

Direct Hire
Negotiable Salary

(sponsorship not available)

Submit resume via: www.bkoutlooks.com



Job Qualifications: |

-Bachelor’s degree in Engineering, science or related field is required.
-3+ years of engineering experience, preferably in a manufacturing environment is required.
-Experience in Process Validation required
-Experience in an FDA-regulated environment preferred.

Job Responsibilities: |

-Develop and execute validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. -Work with customers regarding customer-specific equipment and process validations.
-Facilitate and maintain validation project documentation, including the Site Validation Master Plan.
-Serve as the database administrator for QS (Statistical Process Control) software.
-Provide statistical analysis support for manufacturing, new product development (NPD), trials and validation activities.
-Develop SOPs relating to validation and risk management.
-Monitor and prepare Key Performance Indicators (KPIs) for major customers.
-Conduct quality/engineering studies to support manufacturing operations.
-Facility Corrective Action / Preventive Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques within the manufacturing plant.
-Facilitate and train associates on quality topics required for their positions (SPC / CAPA).
-Coordinate continuous improvement initiatives

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