QA Engineer, Medical Devices (ISO 13485)

Glidewell Dental; Irvine (CA); Vor Ort; USD 70.000 - 100.000; Vollzeit

Zusammenfassung

Glidewell Dental is seeking a Quality Assurance Engineer to embed quality into medical device development and manufacturing. You’ll own quality engineering, risk management, CAPA, validation, and the QMS, collaborating with cross-functional teams to ensure safety, performance, and compliance across products and processes.

The role involves leading investigations, CAPA, design verification, and failure analysis within an onsite Irvine campus; strong analytical and communication skills are

Qualifikationen

• Bachelor's degree in Science, Engineering, or related field; or equivalent combination of experience and training; advanced degree preferred.
• Minimum three (3) years of experience in quality engineering and risk management.
• Knowledge of FDA regulations, ISO 13485, and other applicable international quality standards.
• Knowledge of risk management (ISO 14971), design controls, and validation methodologies.
• Proven analytical, problem-solving, and communication skills.
• Proficiency in quality and statistical analysis tools such as Minitab or equivalent software.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Six Sigma certification, preferred.
• Experience with combination products or Class I/II medical devices, preferred.
• Familiarity with EU MDR and UDI regulatory requirements, preferred.

Aufgaben

• Lead quality assurance activities to drive engineering and technical knowledge.
• Create QA programs and initiatives to ensure product development and manufacturing meet requirements.
• Collaborate on NCR investigations and CAPA actions; drive continuous improvements.
• Work with departments to ensure products and processes meet engineering requirements; include design testing, validation, and risk analysis.
• Identify and implement quality issue prevention and corrective actions.
• Participate in CAPA management and quality engineering projects.
• Engage in design verification testing for design control projects.

Kenntnisse

Quality engineering

Risk management

FDA regulations

ISO 14971

Design controls

Validation methodologies

Statistical analysis (Minitab)

Analytical skills

Communication skills

Quality certifications

Ausbildung

Bachelor's degree in Science/Engineering

Advanced degree preferred

Tools

Minitab

Jobbeschreibung

Glidewell Dental is seeking a Quality Assurance Engineer to embed quality into medical device development and manufacturing. You’ll own quality engineering, risk management, CAPA, validation, and the QMS, collaborating with cross-functional teams to ensure safety, performance, and compliance across products and processes.

The role involves leading investigations, CAPA, design verification, and failure analysis within an onsite Irvine campus; strong analytical and communication skills are