Quality Engineer - Medical Devices CAPA & Compliance

Applied Medical Technology, Inc. (AMT); Brecksville (OH); On-site; USD 70,000 - 100,000; Full time

Job summary

Applied Medical Technology, Inc. (AMT) is seeking a Quality Engineer in the Engineering department to develop, implement, maintain and support quality improvement and manufacturing programs.

You will support the CAPA program and address customer complaints, while guiding QA/QC teams and working with other departments to ensure regulatory compliance. The role emphasizes leading quality investigations, performing risk assessments, data analysis and reporting, and mentoring QA personnel to uphold

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

• Product testing and evaluation
• Maintain employee training
• Annual sterilization testing
• 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
• Provide technical guidance to QA and QC personnel
• 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 and help facilitate continuous improvement, corrective and preventive
• Resource in Engineering Change Order review process
• Mentoring, education and training of QA personnel
• Assume additional responsibilities as necessary at the discretion of QA
• Develop programs and methodologies for analyzing and presenting quality system data
• 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

Data analysis

Statistical analysis

Communication

Independent work

Teamwork

Education

Bachelor's degree in a technical discipline

Tools

MS Office

Mechanical test equipment

Electrical test equipment

Job description

Applied Medical Technology, Inc. (AMT) is seeking a Quality Engineer in the Engineering department to develop, implement, maintain and support quality improvement and manufacturing programs.

You will support the CAPA program and address customer complaints, while guiding QA/QC teams and working with other departments to ensure regulatory compliance. The role emphasizes leading quality investigations, performing risk assessments, data analysis and reporting, and mentoring QA personnel to uphold