Quality Engineer – Med Device Process & Validation

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

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.