ESSENTIAL ACCOUNTABILITIES:

• Facilitate and maintain validation project documentation, including site's Validation Master Plan.
  • Write Protocol.
  • Execute Installation, Operation and Performance Qualification.
  • Write final report for each qualification.
  • Attend formal training on related software and/or equipment.
  • Work closely with customer in development of validation requirements and protocols. Maintain validation protocol
• Serve as the Database administrator for Infinity QS (Statistical Process Control) software.
  • Developing project databases to support Quality inline checks and manufacturing.
  • Add associates to the database and assign login and passwords.
  • Add process(s) and part(s) as necessary to support manufacturing.
  • Update specifications to critical quality measures supporting our customer requirements.
  • Troubleshoot application errors, assign root cause, determine solution and implement solution.
  • Maintain input testing equipment for critical quality measurements.
  • Provide Training on Statistical Process Control
• Provide statistical analysis support for manufacturing, new product development (NPD), trials, and validation activities.
• Develop SOP's relating to validation and risk management.
• Monitor and prepare Key Performance Indicators (KPI's) for major customers.
• Conduct quality/engineering studies to support manufacturing operations.
• Facilitate Corrective Action / Preventative Action (CAPA) activities to identify and resolve root cause issues through sound investigation and effective problem-solving techniques to solve problems within the manufacturing plant.
  • Facilitate KT sessions for CAPA Projects.
  • Execute the Effectiveness Check.
  • Provide Training on the CAPA process
• Facilitate and train associates on quality topics required for their position (SPC / CAPA).
• Coordinate continuous improvement initiatives alongside internal and external (customer or supplier) representatives.

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.)

Quality Engineer I

• 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.

Quality Engineer II

• Bachelor's degree in Engineering, science or related field is required plus three or more years of engineering experience, preferably in a manufacturing environment.
• Technical background in nutritional products, laboratory diagnostics, medical devices, pharmaceutical, or similar industry. Experience in an FDA-regulated environment preferred
• Demonstrated ability to perform technical Non-Conformance investigations and Root Cause Analysis.
• Ability to work independently as well as collaboratively in a team setting with peers and colleagues in a cross functional setting.
• Able to prioritize and handle multiple tasks and ability to meet deadlines in a fast-paced work environment.
• Ability to have a flexible work schedule to support department activities and coordinate with production and validation execution schedules.

PHYSICAL AND MENTAL REQUIREMENTS: (The physical demands described here are representatives of those that must be met by an associate to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions)
1. Must be able to communicate face-to-face and over the phone
2. Occasional lifting up to 35 lbs.
3. Frequent standing/walking. Occasional sitting, bending, twisting, kneeling, climbing, pushing/pulling and reaching.
4. Repetitive hand and foot movement.
5. Work environment includes occasional noise, hot and cold temperatures.
6. Requires ability to read, write, calculate and analyze.

FLSA: Exempt

Grade: 10 or 11