K
KUNTUO, an IQVIA company
Process Design Engineer(J10020)
Skills
RInternal AuditSupply ChainCompliance
2 months ago
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Important information
Contract type:
Permanent
Work mode:
Onsite
Published on:
11 August 2026
What they need
该职位来源于猎聘 职责描述: Key Job Duties & Responsibilities:
- Establish and standardize the corporate-level methodology, templates, review mechanism and approval workflow for PFMEA and Control Plan (CP), and ensure full compliance and consistent implementation across all process development and manufacturing sites.
- Lead end-to-end PFMEA development, risk prioritization (RPN analysis) and mitigation action planning for all new process designs, process changes and NPI projects; define Critical-to-Quality (CTQ) characteristics and Key Process Parameters (KPP), and translate risk control requirements into formal, executable Control Plans.
- Drive the closed-loop linkage between PFMEA and Control Plan: regularly review and update PFMEA based on mass production yield excursions, field failures, customer complaints and root cause analysis results, and synchronize revisions to Control Plans, SOPs and work instructions in a timely manner.
- Strengthen process quality governance throughout the process design cycle, define process control strategies, inspection points, sampling rules and acceptance criteria, and deploy statistical process control (SPC) and measurement system analysis (MSA) to monitor process stability and capability.
- Lead root cause analysis (RCA) and corrective/preventive action for major process quality issues, low-yield incidents and reliability failures; identify gaps in PFMEA risk identification and CP control effectiveness, and drive systematic improvement to prevent recurrence.
- Own the integrity and compliance of process documentation system, including process flow diagrams (PFD), standard operating procedures (SOP), process specifications and work instructions, and ensure all documents are fully aligned with PFMEA risk control requirements and Control Plan specifications.
- Collaborate cross-functionally with quality, production, R&D and supply chain teams to push process quality requirements to be implemented at every execution level; support internal audits, third-party system audits and customer quality audits related to process control.
- Provide technical mentorship and systematic training on PFMEA, Control Plan and process quality methodology to engineering teams, build process quality awareness and capability, and drive a prevention-oriented quality culture.
- Lead continuous improvement projects on process quality system, promote digitalization and intelligent management of PFMEA and CP, and continuously improve process robustness and quality management efficiency. 任职要求: Skills & Qualifications:
- Bachelor’s degree or above in Mechanical Engineering, Electronic Engineering, Materials Science, Industrial Engineering or related technical fields. Master’s degree is preferred. 2. 8+ years of solid experience in process development, process quality engineering or manufacturing quality management in precision manufacturing, optoelectronics, automotive electronics, medical devices or related industries.
- Deep expertise and hands-on leadership experience in PFMEA and Control Plan development, review and on-site implementation; proficient in AIAG-VDA FMEA methodology and quality system requirements.
- Strong proficiency in core quality engineering tools, including PFMEA/DFMEA, Control Plan, SPC, MSA, DOE, 8D problem-solving and Six Sigma methodologies.
- Full understanding of end-to-end process development lifecycle, from NPI process design to high-volume production ramp-up, with proven ability to translate product CTQs into process control schemes.
- Solid knowledge of quality management systems such as ISO 9001, IATF 16949 or ISO 13485, with experience in system audit compliance and customer quality response.
- Strong analytical thinking and cross-functional coordination skills, with a proven track record of leading major process quality improvement projects and delivering measurable results.
- Fluent in English for technical documentation writing, audit communication and cross-regional collaboration.
- Six Sigma Black Belt certification, Certified Quality Engineer (CQE) or equivalent quality engineering qualification.
- In-depth industry experience in precision assembly, optical modules, automotive components or medical device manufacturing.
- Experience in building corporate-level PFMEA/CP management systems or promoting digital FMEA platforms.
- Proven experience in supplier process quality governance and end-to-end quality chain construction.
- Strong project management capabilities, with experience managing multiple quality improvement initiatives simultaneously in fast-paced environments.
- Experience in technical team leadership, methodology development and engineering team capability building.
- Familiarity with advanced quality planning (APQP) and production part approval process (PPAP) frameworks.
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