Quality Engineer Technician
Quality Engineer Technician
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.
Job Type: Full-time
Pay: From $25.00 per hour
Expected hours: 40 per week
Benefits:
401(k)
401(k) matching
Dental insurance
Employee assistance program
Health insurance
Life insurance
Paid time off
Referral program
Vision insurance
Work Location: In person