Scope
This document describes the major responsibilities of the job. It does not include all aspects of the position, such as the potential additional duties assigned by management, and the requirement for flexibility in assisting others for the company’s overall benefit.
Job Summary
The Quality Technician is responsible for inspection of materials, tools, and product for Presidio Medical, including incoming and manufacturing Quality Inspection, and helping support the QMS. This includes maintaining the Quality Lab according to facility practices and managing supplies necessary. The Quality Technician shall assist with maintenance of the QMS, such as leading Document Change orders as necessary. The Quality Technician will work closely with Engineering, Quality and Supply Chain Teams to accomplish daily or routine tasks. This position will be based on site in South San Francisco.
Essential Duties and Responsibilities
• Quality Inspection
o Performs incoming inspection of materials and product on-time and according to inspection specifications released in the QMS
o Maintains clear and concise records to comply with internal procedures and external regulations
o Maintains the Quality Lab according to facility procedures
o Performs production inspections according to written procedures and complete necessary lot or device history records
o Create or modify inspection or process instructions as needed
• Material Handling
o Assemble material and parts for production builds according to internal work orders, including records of traceability
o Assists with material transfer records to maintain traceability of items leaving inventory
o Supports other production and engineering builds and activities, as required
• General
o Troubleshoot and identify areas of improvement in the manufacturing process
o Perform data entry and documentation of work performed, basic computer skills are required.
o Support Engineering, Supply Chain and Quality as needed
o Support Facilities as needed
Qualification Requirements
Experience/Education:
• Minimum 2 years Technical Degree or Trade School or equivalent industrial experience
• 1-3 years related experience in a medical device manufacturing environment preferred
Knowledge/Skills/Abilities:
• Demonstrated proficiency in written and verbal communication
• Basic skills in software applications, such as Microsoft Office, preferred
• Experience with process validations (IQ-OQ-PQ), and calibration and preventive maintenance is a plus
• Knowledge of and compliance with applicable Quality System requirements (e.g., traceability QSRs, ISO)
• Ability to work in a fast-paced environment while managing multiple priorities
• Ability to work independently and detailed-oriented
Physical Demand
• Varied sitting, standing, and walking.
• Ability to lift and carry 50lbs. or less