Quality Assurance Professional

hace 2 meses


San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo

**Job Summary**:

At Viant Medical, we are seeking a highly skilled Quality Assurance Professional to provide quality engineering support to the development and production of Class I, II, and III Medical Devices. The ideal candidate will have a strong background in quality systems, regulatory compliance, and medical device manufacturing.

**Key Responsibilities**:

• Coordinate the development of new processes inspections by interfacing with personnel from product design and development, quality assurance, production, manufacturing, process/assembly technology, and external vendors/customers.

• Participate in the preparation of quality metrics required for Management Review, Operations Review, or Quality Metrics meetings.

• Review drawings, analyze tooling, and recommend improvements leading to increased productivity, quality, and safety for new or existing manufacturing processes.

• Coordinate and carry out qualification and validation activities for new products, processes, changes, and transfers as per FDA regulations (IQ, TMV, OQ, PQ, and Quality Plans).

• Execute investigations for audit non-conformances, complaints, and Corrective and Preventive Actions (CAPA) to correct a problem presented in the quality system or the manufacturing process.

• Responsible for the elaboration of risk management documentation such as Risk Management Plan/Report and Process FMEAs.

• Train Quality Assurance Inspectors and manufacturing personnel in understanding of procedures, specifications, environmental controls, etc.

• Act as a quality system internal auditor.

**Requirements**:

• Bachelor's degree in Engineering or Science (such as Pharmacy, Microbiology, Physics, and Chemistry).

• At least 2 years work experience in a manufacturing environment.

• Project Management experience.

• Bilingual English/Spanish - Advanced English level (written and spoken).

• Knowledge of applicable regulations for the medical device industry (FDA, ISO, other).

• Knowledge of test method validation.

• Knowledge in root cause analysis tools.

• Knowledge of Minitab statistical software.

• Knowledge of Six Sigma Methodology and Lean Manufacturing.

**Equal Employment Opportunity**:

Viant Medical provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws.



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