Quality Engineer

ACE Partners; Minnesota; On-site; USD 75,000 - 95,000; Full time

Job summary

ACE Partners in Minnesota is seeking a Quality Engineer to support manufacturing, process improvement, validation, and product transfer activities within a highly regulated medical device environment.

You will lead CAPA, NCR investigations, IQ/OQ/PQ validations, and risk management in line with ISO 14971, ISO 13485 and FDA GMP guidelines, partnering with Manufacturing, Engineering and Microbiology to resolve quality issues.

Qualifications

• 2+ years of engineering experience with quality engineering methodologies.
• Knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with CAPA, root cause analysis, validation, process improvement, and risk management.
• Strong analytical and communication skills; project management ability.

Responsibilities

• Develop and maintain quality engineering and process control systems.
• Lead CAPA, NCR, nonconformance investigations.
• Develop IQ/OQ/PQ and process validation activities.
• Lead risk management in line with ISO 14971.
• Drive Lean/Six Sigma and continuous improvement.
• Monitor CTQ attributes and process performance.
• Support product transfers and sustaining engineering as Quality representative.
• Partner cross-functionally to resolve quality issues.

Skills

Quality engineering

CAPA

Root cause analysis

Process validation

Lean Six Sigma

Education

Bachelor's degree in Engineering or related field

Job description

A leading medical device manufacturer is looking for a Quality Engineer to support manufacturing, process improvement, validation, and product transfer activities within a highly regulated environment.

What You’ll Do

• Develop and maintain quality engineering and process control systems supporting manufacturing.
• Lead CAPA, NCR, nonconformance, and root cause investigations.
• Develop and execute IQ/OQ/PQ and process validation activities.
• Lead risk management activities in line with ISO 14971.
• Drive Lean/Six Sigma and continuous improvement initiatives.
• Monitor Critical-to-Quality (CTQ) attributes and process performance.
• Support product transfers and sustaining engineering as the Quality representative.
• Partner cross-functionally with Manufacturing, Engineering, Microbiology, and other teams to resolve quality issues.

What They’re Looking For

• Bachelor’s degree in Engineering or a related technical field.
• 2+ years of engineering experience with quality engineering methodologies.
• Strong knowledge of FDA regulations, GMP, ISO 13485, and ISO 14971.
• Experience with CAPA, root cause analysis, validation, process improvement, and risk management.
• Strong analytical, communication, project management, and problem-solving skills.

Great opportunity for a Quality Engineer looking to take ownership of manufacturing quality, validation, process improvement, and product transfer within a global medical device environment.