About SHL Medical

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in Sweden, Taiwan, and the Unites States.

Job Overview

• The Quality Engineer is responsible for supporting 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 with an active role in the processes to ensure products meet quality standards which are consistent with Customer Requirement, while meeting all design controls and regulatory requirements, including but not limited to FDA Quality System Regulation 21 CFR Part 820, ISO 13485, ISO 11608 & ISO 14971.

Main Responsibilities

• Represent quality on product development, process development and product care.
• Ensure design control and process control of the projects meet local and international regulatory, corporate, customer, and local Quality Management System (QMS) requirements.
• Assess and approve the risk mitigation techniques implemented and confirm consistency with the product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls – Failure Mode and Effects Analysis (FMEA), Process-FMEA especially.
• Develop quality controls and work closely with Quality Assurance team on the transfer of quality requirements.
• Promote the use of statistics during engineering study, investigations and evaluations to provide concrete supporting evidence towards decisions.
• Support product development, process development and product care activities of molding/tooling, including the following:
  • Support Design for Manufacture and Assembly (DFMA) activity. Consolidates lessons learned and historical data to influence product design.
  • Review and approve the development documents and activities including User Requirement Specification (URS), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), benchmarking, Design of Experiments (DoE), trial shot, and so on.
  • Develop or review product/process specifications and requirements.
  • Review and approve protocol and report of verification and validation.
  • Create Process-FMEA.
  • Participates in product development, process development and change activities, including design reviews, change control board meetings.
  • Provides technical support for product quality attributes/decisions.
• Contribute to compilation and maintenance of Design History Files (DHF).
• Ensure proper design and development documentation as per ISO 13485/FDA QSR Quality System. 

Minimum Qualifications

• 3 + years of work experience in the regulated environment of medical devices industry/pharmaceutical/biotechnology industry, or similar high-volume precision manufacturing industry.
• Experience in injection molding processes, mold design of plastics, and quality engineering.
• Experience in verification/validation activities such as FAT/SAT and IQ/OQ/PQ.
• Experience in implementing and managing Design Control processes and ensuring compliance with regulatory standards throughout the product lifecycle with comprehensive understanding of medical device regulations such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• In depth know-how and experience of quality techniques: Six Sigma methods, Quality Function Deployment (QFD), Design for Manufacture (DFM),  DMAIC, Design of Experiments (DoE), Failure mode and effects analysis (FMEA), control chart etc.

Preferred Qualifications

• Demonstrated ability to work effectively with cross function teams.
• Strong communication, analytical, and problem-solving skills.
• Experience using statistical tools (such as Minitab etc) and statistical methods (such as DoE, SPC, Acceptance Sampling, Process Capability Analysis etc) for data analysis and process optimization.

Language skills

• English (Speaking and writing)
• Mandarin in Chinese

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.

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.