Quality Engineer Apply
Title : Quality Engineer
Location : Morristown, TN
Compensation: Full Time Plus Benefits
MUST HAVE:
• Three+ years of engineering experience in a manufacturing environment is required.
• Experience in an FDA-regulated environment preferred.
• Must have Process Validation Experience
JOB SUMMARY:
This position develops and executes validation protocols (IQ / OQ / PQ) as required for equipment, sanitization/cleaning, facilities, software, and processes. This job will also work with customers regarding customer-specific equipment and process validations.
ESSENTIAL ACCOUNTABILITIES:
• Facilitate and maintain validation project documentation, including the Site Validation Master Plan.
• Serve as the database administrator for Infinity 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 alongside internal and external (customer or supplier) representatives.
• Demonstrate commitment to the company's RRITE Values of Renew, Respect, Integrity, Teamwork, and Excellence.
• Associates have a direct and important role in ensuring that all work is performed in a safe manner. Effectiveness in carrying out this responsibility is part of each associate's essential accountabilities.
• Contribute to a cooperative working effort by demonstrating a willingness to perform other job-related work, as needed or requested.
QUALIFICATION REQUIREMENTS:
(To perform this job successfully, an individual must be able to perform each of the essential accountabilities satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.)
• Bachelor's degree in Engineering, science or related field is required.
• Three+ years of engineering experience, preferably in a manufacturing environment is required.
• Experience in an FDA-regulated environment preferred.
• Strong self-starter with the ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross-functional setting.
• Demonstrated ability to perform technical Non-Conformance Investigations and Root Cause Analyses.
• Ability to prioritize and handle multiple tasks; ability to meet deadlines in a fast-paced work environment.
• Ability to have a flexible work schedule to support department projects and coordinate with production and validation schedules.
• Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical or similar industry.
