Quality Engineer Technician

Job Summary:

The Quality Engineering Technician will be responsible for ensuring that documentation complies with internal and external quality standards. Fully supports change control, internal and external improvement activities, R&D, Engineering activities and supports manufacturing from a documentation through-put standpoint.

Key Responsibilities:

• Review, initiate, update, and approve Nonconforming Material Reports (NCMRs).
• Maintain and update calibration and preventive maintenance records in the asset management system.
• Ensure timely scheduling and execution of equipment calibration and maintenance activities.
• Support internal and external audits by providing documentation and records related to NCMRs, and equipment maintenance.
• Develop and implement quality procedures.
• Conduct root cause analysis and lead corrective and preventive actions (e.g. CAPA, NCM).
• Collaborate with cross-functional teams to resolve quality issues.
• Monitor and report on quality performance metrics.
• Ensure compliance with industry standards and regulatory requirements (e.g., ISO, FDA, AS9100).
• Support audits (internal, external, customer) and maintain documentation.
• Serves on material review board, works with Operations and Engineering to determine appropriate product dispositions.
• Creates training materials and performs training.
• Able to develop inspection methods to analyze product quality.
• Assist in continuous improvement initiatives related to quality systems and processes.
• Ensure compliance with ISO 13485 and other applicable regulatory standards.
• Generate and analyze quality metrics and reports to support decision-making and process improvements.
• Safety Sensitive position
• Other duties as assigned.

Project Management:

• Proficient in Microsoft Office
• Possess strong technical writing, analytical and problem-solving skills
• Ability to work under minimal supervision and be proactive on tasks and project handling

Skills/Knowledge Requirements:

• Knowledge in quality compliance, ISO 13485 and FDA a plus.
• Strong analytical and problem-solving skills.
• Experience with quality tools and methodologies (e.g., SPC, 8D, CAPA).
• Proficiency in data analysis and reporting.
• Excellent communication and teamwork abilities.

Education, Certifications and/or Work Experience Requirements:

• Bachelor's degree in Engineering, Quality Assurance, or related field.
• At least 2 years experience in Medical Devise industry.