Quality Engineer - Medical Devices & CAPA Expert

Applied-Medical-Technology,-Inc.; Brecksville (OH); Sur place; USD 70 000 - 100 000; Plein temps

Résumé du poste

Applied-Medical-Technology, Inc. is seeking a Quality Engineer in the Engineering department to develop and support quality improvement and manufacturing programs. This role will support the CAPA program and address customer complaints to ensure product quality.

The ideal candidate has a technical degree and 3–5 years of experience in a regulated medical device environment, with proficiency in MS Office and familiar with test equipment. ISO 13485, ISO 14971 and FDA QSR knowledge is preferred.

Qualifications

• Four-year degree in a technical discipline.
• 3–5 years of related experience in a regulated environment (medical devices).
• Proficiency with MS Office.
• Familiarity with mechanical and electrical test equipment.
• Knowledge of medical device manufacturing concepts and procedures.
• Ability to analyze and aggregate data using statistics.
• Experience with ISO 13485, ISO 14971 and FDA QSR is preferred.

Responsabilités

• Lead product quality investigations to a successful conclusion.
• Develop, implement, maintain CAPA programs and address customer complaints.
• Perform risk assessments and provide management recommendations.
• Interface with departments to guide CAPA completion.
• Mentor QA/QC personnel and support regulatory compliance.
• Support manufacturing, new product development, and regulatory to ensure GMP/ISO/FDA compliance.

Connaissances

Data analysis

Quality improvement

Regulated environment

Problem solving

Formation

Four-year technical degree

Outils

MS Office

Test equipment

Description du poste

Applied-Medical-Technology, Inc. is seeking a Quality Engineer in the Engineering department to develop and support quality improvement and manufacturing programs. This role will support the CAPA program and address customer complaints to ensure product quality.

The ideal candidate has a technical degree and 3–5 years of experience in a regulated medical device environment, with proficiency in MS Office and familiar with test equipment. ISO 13485, ISO 14971 and FDA QSR knowledge is preferred.