Manufacturing Engineer

Role Overview

• Oversee the development process of new projects, monitor risks during new project execution; lead development process reviews to ensure compliance.
• Track and organize Design History Files (DHF) to ensure completeness, accuracy, and traceability.
• Lead quality analysis, improvement activities, data collection, and monitoring during early project phases.
• Consolidate issues from the design & development process and design transfer, ensuring timely closure with compliance and completeness.
• Participate in the transfer of new projects from pilot run to mass production.
• Establish quality documentation for new product introduction, sample approval, and process quality control.
• Manage quality objectives for new projects/products, including breakdown, analysis, implementation, and corrective actions.
• Lead process-related validation activities and review validation documentation.
• Oversee quality control of new product/project samples, perform non-conformance analysis, and provide feedback.
• Lead risk analysis activities to ensure compliant and controlled design and development processes.
• Conduct gap analysis for various customer design requirements and standards, and manage change control.
• Participate in design review of new workshops/production lines, and in the planning and execution of equipment/process validation for new line projects.
• Participate in computerized system validation for automated production lines/information systems to ensure data integrity.
• Support internal quality audits, external regulatory inspections, and customer audits by preparing relevant quality documentation, tracking corrective actions, and ensuring closed-loop implementation.
• Complete other ad-hoc tasks assigned by superiors.

Requirements

• Bachelor's degree or above.
• Minimum 3 years of relevant DQA experience preferred; experience with Class III non-active medical devices preferred; internal auditor certification for medical devices or ISO 13485 preferred; experience in external regulatory audits preferred.
• Familiar with design and development processes, understanding quality control key points at each stage and ability to make judgments.
• Proficient in regulations: in-depth understanding and application of China GMP, ISO 13485, ISO 14971; knowledge of EU MDR is a plus.
• Core competencies: strong sense of responsibility, integrity, rigor and attention to detail; excellent communication, coordination, and problem-solving skills; ability to work effectively in cross-functional teams and exert positive influence.
• High execution capability, able to work under pressure, results-oriented, self-motivated, responsive, adaptable to high-intensity project-driven work pace; excellent time management and task prioritization skills.
• Proficient in methodologies: design control, risk management, statistical techniques, verification and validation principles and methods.
• Documentation skills: excellent technical writing and review abilities; English reading and writing proficiency.
• Team player, able to quickly adapt to a team-oriented work environment and communicate effectively with internal and external parties.
• Strong big-picture perspective, able to view things from multiple dimensions.

Benefits

• Equal Opportunity Employer: Dentsply Sirona is an Equal Opportunity Employer.
• Assistance: If you need assistance with completing the online application due to a disability, please send an accommodation request to accommodationrequest@dentsplysirona.com.