Quality Engineer - Medical Devices & CAPA Champion

Applied Medical Technology, Inc.; Brecksville (OH); On-site; USD 65,000 - 85,000; Full time

Job summary

Applied Medical Technology, Inc. is seeking a Quality Engineer to develop, implement, maintain and support quality improvement and manufacturing programs. This role supports the CAPA program and addresses customer complaints.

The position collaborates with engineering, manufacturing and regulatory teams to ensure products meet GMP, ISO and FDA requirements and to drive quality improvements across the organization.

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 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

• Product testing and evaluation
• Lead product quality investigations to a successful conclusion
• Execute risk assessments, collect supporting information and provide recommendations for management consideration
• Interface with other departments to provide guidance on CAPA completion
• Represent quality interests and concerns on project teams
• Support manufacturing, new product development, and regulatory to ensure systems are compliant with all internal and external 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
• Adhere to and ensure compliance with Quality System SOPs, work instructions, drawings, GMP, ISO, and FDA requirements

Skills

Analytical skills

Communication skills

Teamwork

Independent work

Education

Four year degree (technical)

Tools

MS Office

Electrical test equipment

Mechanical test equipment

Job description

Applied Medical Technology, Inc. is seeking a Quality Engineer to develop, implement, maintain and support quality improvement and manufacturing programs. This role supports the CAPA program and addresses customer complaints.

The position collaborates with engineering, manufacturing and regulatory teams to ensure products meet GMP, ISO and FDA requirements and to drive quality improvements across the organization.