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
#jobs
#bkoutlooks
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
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
#jobs
#bkoutlooks
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