Manufacturing Engineer

Dentsply Sirona

. Oversee the development process of new projects, monitor risks during new project execution; lead development process reviews to ensure compliance.

Posted 4/23/2026full-timeTianjin • 🇨🇳 ChinaMid-LevelSeniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

DQAdesign controlrisk managementstatistical techniquesverification principlesvalidation principlesquality controlnon-conformance analysisgap analysisdocumentation skills

Soft Skills

strong sense of responsibilityintegrityattention to detailexcellent communicationcoordination skillsproblem-solving skillshigh execution capabilityresults-orientedself-motivatedtime management

Certifications

Bachelor's degreeinternal auditor certification for medical devicesISO 13485