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 (PQE) is responsible for supporting new process development, injection moulding and assembly process 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

Main Responsibilities

• Represents Quality Engineering and quality requirements on process and equipment design & development, with a focus on, but not limited to, plastic component manufacturing / injection molding process development, 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 Process-FMEA, and other risk assessment tools to ensure the identification of critical process parameters, and that 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, manufacturable Design Outputs and their translation into DMRs through an efficient design transfer process (Design for Manufacturing)


• 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.


• Ensure proper design and development activities and documentation as per ISO 13485/FDA QSR Quality System.

Minimum requirements

• Minimum 5 years of work experience in New Process Development, Process and Equipment/System development and qualification function in medical devices and/or other regulated industry (e.g., aviation, automotive)


• Master’s degree in engineering or life science field (or equivalent experience).


• Strong understanding of injection molding processes


• Hands on experience in Advance Product Quality Planning and Control Plan (APQP), and practical in-depth know-how and experience of quality techniques; Six Sigma methods, Quality Function Deployment (QFD), Process 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


• Great understanding and demonstrated experience in applied statistics


• Strong analytical, and problem-solving skills


• Strong writing and verbal communication skills (technical writing, risk documentation, stakeholder alignment, coaching and influence).

• Fluent in written and spoken English.

Preferred Qualifications

• Prior involvement in technology transfer projects across sites or regions


• Experience working with external suppliers, on technical reviews and quality assurance


• Experience with mechanical design (CAD, tolerance analysis)


• Sigma certification (Green Belt minimum; Black Belt preferred) or equivalent demonstrated competence


• Fluent in written and spoken English.

We Offer

• Challenging assignments in a fast-growing and innovative industry. 


• An exciting opportunity in a fast-growing international medical technology company.


• A modern working environment with multicultural and dynamic teams.


• A centrally located office in Zug, very close to the train station.

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.