Quality Engineer II

Summary

The Quality Engineer II supports manufacturing and validation activities within a regulated medical device environment. This role is responsible for executing and reviewing process validations, equipment qualification, and computer system validation activities to ensure compliance with regulatory and quality requirements. The position collaborates closely with Engineering, Manufacturing, and Quality teams to support product quality, process control, and continuous compliance.

• Perform and/or review Process Validation (PV) activities including characterization, OQ, and PQ (excluding cleaning validations).
  


• Execute and support Equipment Qualification and Computer System Validation (CSV) activities including URS, FAT, IQ, OQ, PQ, and TMV (non\-laboratory systems).
  


• Support the definition and execution of validation strategies, including requirements flow\-down from design to manufacturing.
  


• Develop, review, and maintain risk management documentation, including pFMEA.
  


• Support validation\-related projects involving design requirements validation and manufacturing controls.
  


• Investigate manufacturing process events and support product disposition activities.
  


• Assess, trend, and analyze manufacturing defects, nonconformances, and reject data.
  


• Support Design Transfer activities to ensure smooth transition from development to manufacturing.
  


• Collaborate with Engineering and Manufacturing to establish and maintain quality standards and protocols.
  


• Develop, apply, and maintain inspection, testing, and evaluation methods for products and production equipment.
  


• Perform basic statistical analysis to evaluate process performance and product quality (Minitab preferred).
  


• Ensure corrective actions meet reliability standards and documentation complies with regulatory and internal quality requirements.
  


• Support quality assurance testing and continuous improvement initiatives.
  

Requirements

Required Qualifications (Must Have)

• Education: Bachelor’s degree in Engineering.
  

  
  
  
  

  • Mechanical, Electrical, or Chemical Engineering preferred.
    

  
  



• Experience:
  

  
  
  
  

  • Minimum 2+ years of experience in validation processes.
    

  
  

  • Hands\-on experience with Process Validation (PV) and Equipment Qualification / CSV.
    

  
  



• Experience with risk management documentation, including pFMEA.
  




• Basic knowledge of validation strategy development.
  




• Basic statistical knowledge; experience using Minitab preferred.
  




• Experience supporting projects related to manufacturing controls and design requirements validation.
  




• Ability to work onsite and flexible schedules as required.
  

Preferred Qualifications (Nice to Have)

• Experience investigating manufacturing operations events in support of product disposition.
  




• Experience trending and analyzing manufacturing defects or reject data.
  




• Knowledge of Medical Device regulations.
  




• Experience supporting Design Transfer activities.
  




• Experience working within regulated manufacturing environments.
  

Work Schedule & Availability Requirements

• Availability to work extended shifts (8–12 hours per shift)
  




• Availability to work weekends (Saturday and/or Sunday)
  




• Availability to work holidays as required
  




• Availability to work first and/or second shift as required
  




• 100% On\-site position