Overview
OSI Systems companies have a long history of developing innovative solutions to bring a better quality of life to the world. Our OSI Electronics (OSIE) division is a diversified manufacturer of electronic devices and value-added manufacturing services.
We provide our customers with the manufacturing capabilities and purchasing power of a global Electronics Manufacturing Services provider. By delivering regional and personalized support best provided by a smaller company, we strive to build lasting relationships and create close and valued partnerships with our customers. Our singular focus is to help security experts, clinical professionals and high-tech developers solve real-world problems and issues.
PFC Flexible Circuits Limited, a division of OSI Electronics, is seeking a Quality Engineering Technician who supports the implementation and maintenance of the Quality Management System by performing inspections, testing, data analysis and validation activities to ensure products meet specified requirements and industry standards. The role assists in root cause analysis, corrective actions, process validations, and qualification of manufacturing and testing equipment. Additionally, the technician helps maintain accurate quality records and supports audits and compliance with applicable standards such as ISO and AS9100.
This individual will support day shift operations (7:30am - 4:00pm).
Responsibilities
- Lead the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for new and existing manufacturing processes, equipment, and customer products.
- Prepare First Article Inspection (FAI) reports in accordance with AS9102 requirements, including ballooned drawings, verification of all design characteristics, and traceability of materials and special processes.
- Perform Measurement System Analysis (MSA), including Gage Repeatability and Reproducibility (Gage R&R) studies, to ensure the accuracy and reliability of inspection and test methods.
- Perform validation of software systems used in production and quality processes ensuring compliance with applicable standards (e.g., ISO 13485, AS9100) and internal procedures.
- Prepare and maintain Production Part Approval Process (PPAP) documentation, including PSW, control plans, PFMEA, process flow diagrams, and supporting records, ensuring compliance with customer-specific requirements.
- Develop, schedule, and monitor preventive maintenance and calibration programs for production and facility equipment; coordinate with external vendors and service providers for maintenance and repair activities.
- Support root cause analysis activities (e.g., 5-Why, 8D) for nonconformances and assist in the implementation and verification of corrective and preventive actions (CAPA).
- Participate in internal and external audits, including audit preparation, evidence collection, and follow-up on corrective actions.
- Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
- Demonstrate behavior consistent with the company’s Code of Ethics and Conduct.
- It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
- Duties may be modified or assigned at any time to meet the needs of the business.
Qualifications
Required
- Bachelor's degree in Engineering (Mechanical, Electrical, Industrial, or related discipline) or equivalent technical experience in a manufacturing environment with focus on Quality.
- At least six (6) months’ experience in quality engineering, process validation, or manufacturing engineering, preferably in aerospace, medical device, or electronics/PCB industry.
- Strong understanding of statistical methods and data analysis for process validation.
- Strong written and verbal communication skills for technical reports and customer interactions.
- Proficient in Microsoft Office (Excel, Word, PowerPoint); experience with ERP systems (e.g., D365) is an asset.
- Proactive attitude with a strong desire to learn and contribute to a regulated environment.
- Excellent attention to detail and strong organizational skills.
Desired
- Familiarity with Quality Management Systems (QMS) and regulatory standards (ISO 9001), ISO 13485 and possibly AS9100.
- Understanding of software validation principles per ISO 13485 and/or GAMP guidelines.
- Familiarity with calibration systems, equipment control, and vendor coordination.
- Working knowledge of AS9100 / ISO 9001 / ISO 13485 quality management systems
- Knowledge of AS9102 First Article Inspection (FAI) requirements.
Pay may range from $24.00 to $24.00 hourly
OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.
