QE - (Senior) Process Quality Engineer (Assembly & Automation)

SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.

【Job Overview】

The Quality Engineer of Process - Automation & Assembly is responsible for supporting new product development, process development and product care through the application of Quality engineering skills for medical devices.

This person will handle projects and tasks, from product/process inception through product launch, scale-up and maintenance and play an active role in the processes to ensure products meet quality standards consistent with Customer Requirement, while meeting all design control and other regulatory requirements, including, but not limited to FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 11608 & ISO 14971.

【Responsibilities】

• Represents Quality on process design, equipment development, and product transfer projects through Product Lifecycle.
• Ensures that all design control and process/production control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements.
• Assesses failure modes and approves the risk mitigation tool, techniques, good practices to ensure the risk management processes are consistent with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – DFMEA, PFMEA, and other risk assessment in system level.
• Practices Quality Function Deployment (QFD) method to evaluate control action from Customer, Design, to Process-wise.
• Promotes the use of statistics in the pre-study, engineering investigation, and in-process control based on quality aspects.
• Supports Device product/process development and product transfer activities, including the following:

       - Consolidates or reviews lessons learned and historical data to influence product design.

       - Supports or reviews process/equipment specifications and requirements including system level.

       - Supports or reviews process/equipment verifications activity (protocols and reports) and validation/test plans.

       - Participates in product or process/equipment design and change activities, including qualification and reviews.

       - Participates in risk management activities including review failure mode effects analysis (FMEA) and/or risk or statistical analysis.

       - Provides technical support for product and process quality attributes/decisions.

       - Support selected qualification activities (e.g., advanced inspection performance check, sterilization validation, etc.) with external suppliers.

• Contributes to compilation and maintenance of Design History Files (DHF).
• Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System.

【Required Skills & Qualifications】

(1) Education:

• Technical / scientific degree at college / university level (mechanical, industrial, biomedical, chemical, system, material engineering and engineering management).

(2) Experience:

  - Occupational experience -

• At least 5 years of work experience in a New Process Development, Design Assurance, Advanced Equipment/System Qualification function in a regulated environment (medical devices/Diagnostic instrumentation industry, pharmaceutical, biotechnology industry, or similar high-volume precision manufacturing industry).
• Experience in modular automation/fully automated assembly processes, particularly those involving plastic injection molded parts, mechanical spring, metallic fastener, with integrated/non-integrated testing, and in-process inspection by vision system.
• Experience in the design and development of products/processes in accordance with ISO 13485 guidelines is a plus.
• In-depth know-how and experience of quality techniques: Six Sigma Greenbelt, Six Sigma methods, Quality Function Deployment (QFD) such as DFSS, DMAIC, DoE, FMEA, control chart etc.
• Experience in the entire Design Lifecycle and Phase-Gate development process.
• Experience in Measurement System Analysis (MSA) and Gauge Repeatability and Reproducibility (GR&R) is a plus.
• Experience in GAMP5 V model and verification/validation activities such as FAT/SAT and IQ/OQ/PQ is a plus.
• Strong communication, analytical, and problem-solving skills.

  - Special knowledge, expertise, experience -

• cGxP Know-How including regulations ISO 13485, FDA 21 CFR 820, FDA 21 CFR Part11, MDD 93/42/EEC.
• GAMP5 Know-How including verification (FAT/SAT) and validation (IQ/OQ/PQ).
• Statistical methods and analysis like DoE, SPC, Acceptance Sampling, Process Capability Analysis etc.
• Statistical tools such as Minitab or JMP etc.
• SAP, Manufacturing Execution Systems (MES) will be an advantage.
• English (spoken and written), local language (Mandarin) is a plus.