About SHL Medical

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview

The Process Quality Engineer of Assembly and Automation is responsible for supporting new process development, automation equipment development and product transfer 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, deployment and retrofit, 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, 21 CFR Part11, ISO 13485, IEC60812 & ISO 14971.

Main Responsibilities

• Represents Quality on new process introduction, equipment development, and tech transfer projects through Lifecycle.
• Ensures that all design control and process control projects meet applicable regulatory (local and international), Corporate, Customer, and Local QMS requirements.
• Assesses failure modes and approves the control measures, techniques, good practices to ensure the risk management processes are consistent with the product specification, hazard and severity associated with device function, process controls, requirement for manufacturing, and control effectiveness – PFMEA and other risk assessment in system level.
• Contributes to compilation and maintenance of Process failure mode effects analysis (P-FMEA).
• Practices Quality Function Deployment (QFD) method to evaluate control action from Customer, Design, to Process-wise.
• Promotes the use of statistics in pre-study, engineering investigation, and in-process control based on quality aspects.
• Supports Device product and process development and technical transfer activities, including the following:
• Provides early risk assessment in Design for Manufacturing and Assembly (DFM&A) to influence product design.
• Consolidates or reviews lessons learned and historical data to influence critical quality attributes to process.
• Reviews process/equipment requirements and change activities of product design including system level.
• Reviews process/equipment design and specifications, including design feasibility study and design qualification.
• Reviews process/equipment verifications and validations activity including protocols and reports.
• Supports technical or engineering activities such as feasibility study, engineering investigation, and supplier qualification process (e.g. component level, post-process, and other manufacturing needs).
• Supports knowledge and technical transfer to PQE team of receiving site for new site development.
• Ensures proper design and development documentation as per ISO 13485/FDA QSR Quality System.

Minimum Qualifications

• At least five 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.
• In-depth know-how and experience of quality techniques: Six Sigma Blackbelt, 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).
• Experience in GAMP5 V model and verification/validation activities such as FAT/SAT and IQ/OQ/PQ.
• Strong communication, analytical, and problem-solving skills.

Language skills 

• Must have: Fluent in English
• Nice to have: Mandarin

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department.For more information on SHL Medical, please visit: shl-medical.com/careers

Please note: We do not accept applications from recruitment agencies for this position.