[ QA ]- Engineer (Product)
About the job
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. 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
This position is to provide quality oversight to assure design, development, manufacturing and post-market of SHL product are compliant to applicable regulations, standards, and SOPs. QA engineer ensures the delivery of high quality product which meet the regulatory requirements and customer expectations.
Main Responsibilities
- Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team.
- Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement.
- Complete the evaluation and detailed investigation on the observed non-conformities during manufacturing process.
- Present accumulated quality data to customers and management.
- Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues.
- Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines.
- Support external quality inspections and execute internal and supplier audits.
- Complete assigned tasks on time with minimal supervision (self-motivated).
Required Skills & Qualifications
- BS degree above or equivalent technical work experience.
- Clear / logical thinking with strong organization and communication skills
- Proficient problem solving skills.
- Working knowledge of Microsoft Office.
- Experience in the medical device industry is preferred.
- Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
- CQT (certified quality technician), CQE (certified quality engineer) is a plus.
- Six sigma green belt or black belt is a plus.
We offer
- Competitive compensation package.
- Modern & variety of culture 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.