Senior Process Quality Engineer

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 United States.

Job Overview

The Process Quality Engineer (PQE) is responsible for supporting new process development, automation equipment development and product transfer by applying quality engineering skills in compliance with medical devices industry standards and regulations. Sr PQE will handle projects and tasks, from product/process inception through product launch, scale-up, deployment, and retrofit projects. The Process QE will also be key in ensuring that Customer Requirement, Quality & Compliance requirements are constantly met including, but not limited to FDA Quality System Regulation 21 CFR Part 820, 21 CFR Part11, ISO 13485, ISO 14971, and applicable technical standards.

Responsibilities:

• Represents Quality Engineering and quality requirements on process and equipment design & development (i.e. plastic and metal component manufacturing process development, assembly) throughout the Product Lifecycle.
• Leads control planning activities, practices Quality tools (i.e. TQM, QFD, Risk Assessments) to evaluate control action for process/equipment
• Leads and facilitates best practices of DFMEA, PFMEA, and other risk assessment tools in system level to ensure the risk controls are identified, implemented and effective
• Promotes the risk-based and scientific approach to process and equipment design & development,
• Promotes the use of applied statistics in engineering studies and investigations,
• Consolidates and reviews lessons learned and historical data for robust and risk-free process
• Supports the creation of robust Design Outputs and their translation into DMRs through an efficient design transfer process
• Supports and reviews process/equipment verifications activity (engineering runs, protocols and reports)
• Supports the validation activities (engineering studies, DOEs, IQ/OQ/PQ) planning and execution
• Support selected qualification activities (e.g., advanced inspection performance check, sterilization validation, etc.) with external suppliers.
• Ensures proper design and development activities and documentation as per ISO 13485/FDA QSR Quality System.

Minimum requirements:

• Minimum 5 years of work experience in a New Process Development, Design Assurance, Process and Equipment/System development and qualification function in medical devices and aviation/automotive industry
• Hands on experience in Advance Product Quality Planning and Control Plan (APQP)
• Six Sigma Black Belt, In-depth know-how and experience of quality techniques; Six Sigma methods, Quality Function Deployment (QFD), Capability analysis, ANOVA, DMAIC, DoE, FMEA, control chart etc
• 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

Preferred requirements:

• Experience in application of APQP tools and techniques, ICH Quality by Design approach for Control Planning
• Great understanding and demonstrated experience in applied statistics
• Strong analytical, and problem-solving skills
• Strong writing and verbal communication skills
• 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 Total Productive Maintenance, Reliabilty Centered Maintenance

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including your CV, motivation letter, and all other relevant documents  directly to RecruitCH@shl-group.com.

Please note: For this position, we do not consider applications from recruitment agencies.