Quality Assurance Engineer

SHL Medical AG is a 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.

Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. The strong competition around the globe, comes from the Intelligence property we owned in Europe and USA, the vertical integration from the tool design, to state of art industrial 4.0 footprint throughout the processes and great QMS/RA intelligence to ensure we deliver the most reliable products. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

Job Overview

Coordinate on total quality activity to ensure that the organization’s quality system comply with all relevant standards, regulations, licenses and certifications. Products and services are conforming to specifications; meet internal and external quality expectations.

Responsibilities

1. Work with cross-functional team to drive the CLCA processes.
2. Drive quality improvements by eliminating sources of defects in the supplier, new product introduction, and manufacturing processes.
3. Utilize product and process lessons learned to drive preventative actions and improvement plans.
4. Implement the supplier quality management process across all suppliers / subcontractors.
5. Provide quality support and resources to manufacturing in the use of incoming materials.
6. Lead quality improvement initiatives and investigations to suppliers’ issues.
7. Communicate and implement quality requirements to all suppliers.
8. Strong problem solving skills using analytical and data-driven approach.
9. Ability to communicate clearly through oral and written communications and present clear and concise information to team and customers.

Requirements

1. 3+ years of quality-relevant experience in a quality system regulated company
2. Familiar with ISO 9001, 13485 standard
3. The candidate should be prudent and detail-oriented with strong logical reasoning and analytical skills
4. Good command of English ability in listening, speaking, reading and writing (TOEIC 800)
5. Knowledge of GMP and QSR is a plus

We offer
• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization