Quality Engineer III - Medical Device, Risk & Validation

JMD Technologies Inc.; Bethel (CT); Sur place; USD 62 000 - 69 000; Plein temps

Résumé du poste

JMD Technologies Inc. in Bethel, CT seeks a Quality Engineer III for a 6+ month contract to support new product introductions, risk management, and validations in a medical device manufacturing environment.

You will apply quality tools, lead root cause investigations, and develop test methods for equipment and process qualifications, with ISO 13485 and FDA 21 CFR 820 awareness required.

Qualifications

• Bachelor's degree in engineering or a related field.
• 2+ years in a quality engineering role in medical device manufacturing or startup.
• Familiar with ISO 13485 standards and FDA 21 CFR 820 regulations.
• Proven experience creating quality documentation.

Responsabilités

• Quality engineering and process improvement.
• Lead risk management and mitigation activities.
• Root cause analysis and corrective actions.
• Develop and qualify tests for equipment, processes, and products.
• Support validation activities.
• Maintain compliance documentation.

Connaissances

Quality engineering

Root cause analysis

Documentation

Risk management

Process improvement

Formation

Bachelor's degree in engineering

Description du poste

JMD Technologies Inc. in Bethel, CT seeks a Quality Engineer III for a 6+ month contract to support new product introductions, risk management, and validations in a medical device manufacturing environment.

You will apply quality tools, lead root cause investigations, and develop test methods for equipment and process qualifications, with ISO 13485 and FDA 21 CFR 820 awareness required.