Quality Engineer - Medical Devices, CAPA & ISO 13485

AirClean Systems, Inc.; Brecksville (OH); Vor Ort; USD 75.000 - 105.000; Vollzeit

Zusammenfassung

AirClean Systems, Inc. is seeking a Quality Engineer in the Engineering department. The role reports to the Director of Regulatory Affairs and focuses on developing, implementing, and maintaining quality programs to improve manufacturing processes.

You will lead CAPA activities, perform product quality investigations, and ensure systems comply with GMP, ISO, and FDA requirements. Strong data analysis and problem-solving skills are essential.

Qualifikationen

• Four year degree, preferably in a technical discipline.
• 3-5 years related experience in a regulated environment, preferably medical device.
• Proficiency with MS Office.
• Familiarity with use of mechanical and electrical test equipment.
• Knowledge of commonly used concepts, practices, and procedures related to medical device manufacturing.
• Ability to analyze and aggregate data using statistics.
• Experience preferred with ISO 13485, ISO 14971 and FDA QSR for Medical Devices.

Aufgaben

• Develop, implement, maintain and support quality improvement and manufacturing programs.
• Support the CAPA program and address customer complaints.
• Lead product quality investigations to a successful conclusion.
• Execute risk assessments and provide management with recommendations.
• Ensure compliance with GMP, ISO and FDA requirements.

Kenntnisse

Statistical analysis

Problem solving

Documentation & reporting

Quality systems knowledge

Ausbildung

Four year technical degree

Tools

Microsoft Office Suite

Mechanical test equipment

Electrical test equipment

Jobbeschreibung

AirClean Systems, Inc. is seeking a Quality Engineer in the Engineering department. The role reports to the Director of Regulatory Affairs and focuses on developing, implementing, and maintaining quality programs to improve manufacturing processes.

You will lead CAPA activities, perform product quality investigations, and ensure systems comply with GMP, ISO, and FDA requirements. Strong data analysis and problem-solving skills are essential.