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

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 (Assembly & 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 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.

Main 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.

Minimum 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 2+ 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.
• Entry level(junior role)/ In-depth(senior role) 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.
• 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.
• Fluent in English (spoken and written)

Preferred Qualifications

- Occupational experience -

• Experience in the design and development of products/processes in accordance with ISO 13485 guidelines is a plus.
• 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.

  - 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.
• Local language (Mandarin) is a plus.

We Offer :

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy. 

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.