Equipment Quality Engineer

HCLTech is looking for a highly talented and self- motivated Equipment Quality Engineer to join it in advancing the technological world through innovation and creativity.

Job Title: Equipment Quality Engineer

Job : 76431

Position Type: Full-time with HCLTech

Location: Santa Clara, CA

Key Purpose of the Job:

The Equipment Quality Engineer is responsible for the calibration, preventive maintenance, and lifecycle management of equipment supporting the development and manufacturing of complex electromechanical medical devices. This role ensures equipment compliance with the company’s Quality Management System (QMS) and applicable regulatory requirements.

The position supports both R&D and Operations across all phases of the product lifecycle and works closely with cross functional teams, external service providers, and Quality leadership. Daily activities are managed through the Computerized Maintenance Management System (CMMS) and documentation systems.

DUTIES / RESPONSIBILITIES :

• Coordinate and execute preventive maintenance (PM) and calibration activities for GxP equipment to ensure compliance with QMS and regulatory requirements.
• Maintain PM and calibration schedules in the CMMS (SAP) and ensure activities are completed on time with minimal impact to production.
• Perform quality review of calibration, maintenance, and equipment documentation, including calibration certificates, equipment histories, and PM records.
• Initiate Nonconforming Reports (NCRs) when equipment is found to be out of tolerance or noncompliant and support investigation activities.
• Notify equipment owners and users of upcoming or overdue PM and calibration activities.
• Coordinate with external calibration and maintenance service providers, including scheduling, shipping, tracking, and receipt of equipment.
• Create and track purchase requisitions for PM and calibration services.
• Review equipment documentation and consult with equipment owners regarding specific calibration and measurement requirements.
• Create, review, and maintain calibration and maintenance reports.
• Track, trend, and analyze PM and calibration data and provide recommendations for program and equipment improvements.
• Review and support equipment-related change orders and change control activities.
• Maintain complete and accurate documentation for PM plans, calibration certificates, equipment histories, validation artifacts, and change records in accordance with Good Documentation Practices.
• Support internal and external audits, inspections, and regulatory assessments.
• Participate in the development, review, and update of procedures, protocols, and checklists related to equipment calibration and maintenance.
• Support continuous improvement projects related to documentation management systems (DMS/SAP) and equipment quality processes.
• Communicate business-related issues and improvement opportunities to management.
• Follow all company policies related to health, safety, environmental, and regulatory compliance.
• Perform other duties as assigned.

Education & Experience

• Associate degree (AA/AS) or technical certification in a related field required.
• Bachelor’s degree in Engineering or a related discipline preferred.
• Minimum of 3 years of experience in equipment calibration and preventive maintenance within a regulated (GxP) environment.
• Experience working in a cGMP environment with strong documentation practices required.

Skills & Abilities

• Working knowledge of FDA Quality System Regulations (21 CFR Part 820) and ISO 13485.
• Experience with Computerized Maintenance Management Systems (CMMS), preferably SAP.
• Familiarity with measuring and test equipment, including calipers, micrometers, gage blocks, torque tools, and production equipment.
• Strong attention to detail and organizational skills.
• Ability to work independently, prioritize activities, and manage multiple tasks with minimal supervision
• Strong analytical, problem solving, written, and verbal communication skills.
• Proficiency in Microsoft Office applications (Word, Excel) or equivalent software.
• Ability to effectively collaborate with cross functional teams and external suppliers.

DESIRED EXPERIENCE (Optional)

• Experience in the medical device or life…