Quality Engineer - Medical Devices, CAPA & Compliance

AirClean Systems, Inc.; Brecksville (OH); On-site; USD 75,000 - 105,000; Full time

Job summary

AirClean Systems, Inc. in Ohio seeks a Quality Engineer to develop, implement, and support quality improvement initiatives across manufacturing. You will engage in CAPA, investigations, and data analysis to ensure compliance with GMP, ISO 13485, and FDA QSR.

The role partners with engineering and regulatory teams to drive product quality from design through production, mentor QA staff, and help maintain robust quality systems and supplier controls.

Qualifications

• 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

Responsibilities

• Develop, implement, maintain and support activities for 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.
• Interface with other departments to provide guidance on CAPA completion.
• Provide technical guidance to QA and QC personnel.
• Represent quality interests on project teams.
• Support manufacturing, new product development, and regulatory to ensure systems are compliant with GMP, ISO and FDA requirements.
• Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection.
• Collect, analyze, trend and communicate quality data throughout the organization.
• Identify program opportunities for improvement and drive procedure updates when required.

Skills

MS Office

Statistical analysis

Medical device manufacturing

Regulatory standards

Education

Bachelor's degree or Four Year degree in technical discipline

Job description

AirClean Systems, Inc. in Ohio seeks a Quality Engineer to develop, implement, and support quality improvement initiatives across manufacturing. You will engage in CAPA, investigations, and data analysis to ensure compliance with GMP, ISO 13485, and FDA QSR.

The role partners with engineering and regulatory teams to drive product quality from design through production, mentor QA staff, and help maintain robust quality systems and supplier controls.