About The Job

Our client is looking for a Quality Engineer who will help make sure that everything we make meets high standards and passes inspections. You'll help with keeping our cleanroom certified, checking that our measurement tools are accurate, and improving our quality systems. You'll also look into customer complaints, help us follow industry rules, and sometimes audit our suppliers.

This is a mid-level role for someone who has done this kind of work for a few years and is comfortable working alone or on a team.

Key Responsibilities (What You'll Be Doing)

• Take charge of cleanroom and environmental monitoring programs.
• Ensure all gauges and tools used for inspections are accurate.
• Find ways to improve the quality system and processes.
• Support supplier evaluations and performance tracking.
• Conduct internal and supplier audits.
• Help investigate and document quality issues or customer complaints.
• Be a backup to other QA/RA team members when needed.
  
  

equired Skills (Must-Have)

• Bachelor's degree in engineering or science.
• 5+ years in a quality assurance or quality control role.
• Experience working with ISO 13485 or 21 CFR Part 820 standards.
• Strong skills in Microsoft Word and Excel.
• Excellent communication, both written and verbal.
• Able to work independently and as part of a team.
• Motivated, organized, and able to solve problems quickly.
  
  

Nice To Have (Preferred But Not Required)

• Master's degree in engineering or science.
• Certifications like CQE, CQM, CQA, CQI, or CQT.
• Experience using Minitab or advanced Excel tools.
• Knowledge of medical devices and sterilization (Ethylene Oxide preferred; Gamma is a plus).
• Able to travel for work (domestic and international).