Quality Engineer - Medical Device, CAPA & Compliance

Applied Medical Technology, Inc.; Brecksville (OH); In loco; USD 70.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, dental and vision coverage

Relaxed work environment and casual-d

Small-company culture

Design, engineering and manufacturing…

Descrizione del lavoro

Applied Medical Technology, Inc. in Brecksville, OH is seeking a quality-focused professional to develop, implement, and maintain quality improvement programs.

You will support CAPA and address customer complaints while leading product quality investigations and risk assessments. The role requires a four-year degree in a technical field, 3–5 years in a regulated environment, and experience with ISO 13485, ISO 14971, and FDA QSR for Medical Devices.

Competenze

• Four Year degree or higher, 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.

Mansioni

• 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 recommendations for management.
• Interface with other departments to guide CAPA completion and ensure regulatory compliance.
• Provide technical guidance to QA and QC personnel.
• Represent quality interests on project teams and support manufacturing, new product development, and regulatory to ensure systems are compliant.
• Investigate causes of quality problems identified at incoming inspection, manufacturing and final QC inspection.
• Collect, analyze, trend and communicate quality data across the organization.
• Identify opportunities for continuous improvement and drive corrective and preventive actions.

Formazione

Bachelors degree

Descrizione del lavoro

Applied Medical Technology, Inc. in Brecksville, OH is seeking a quality-focused professional to develop, implement, and maintain quality improvement programs.

You will support CAPA and address customer complaints while leading product quality investigations and risk assessments. The role requires a four-year degree in a technical field, 3–5 years in a regulated environment, and experience with ISO 13485, ISO 14971, and FDA QSR for Medical Devices.