Quality engineer Morristown TN

Job Description

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Experience level: Mid-senior Experience required: 3 Years Education level: Bachelor’s degree Job function: Engineering Industry: Consumer Goods Compensation: $61,000 - $80,000 Total position: 3 Visa sponsorship eligibility: No

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.

Skills