Quality Control ENGR

SHL Medical is the world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5,000 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】

We are seeking a detail-oriented and experienced IQC/OQC (Incoming Quality Control/Outgoing Quality Control) Engineer to join our quality control team. The successful candidate will be responsible for ensuring the quality of incoming materials and outgoing products, developing and implementing quality control procedures, and collaborating with various departments to maintain high quality standards.

【Main Responsibilities】

1. Conduct incoming and outgoing quality inspections on raw materials, components, and finished products
2. Develop, implement, and maintain quality control procedures and standards
3. Analyze quality data and prepare reports for management
4. Investigate quality issues and implement corrective actions
5. Collaborate with SQA/suppliers to resolve quality-related problems
6. Train and supervise quality control inspectors
7. Participate in continuous improvement initiatives
8. Ensure compliance with medical standards and regulations
9. Maintain accurate documentation of quality control activities

This role is expected to focus on the following areas:

• 30% – IQC/OQC process improvement
• Label attachment optimization
• Melt Indexer inspection exemption
• IQC method verification process WI (On-going)
• 30% – CI Lean Champion responsibilities
• Cooridnation among external departments and CI team.
• Professional A3 initiatives presentation
• IDL Kaizen presentation Coaching/ Mentoring
• DL Kaizen initiative
• 20% – QC inspection integration
• IQC U-Bracket measurement method consolidation (On-going)
• IQC/ IPQC RNS Remover measurement method consolidation
• 20% - Cross-site support/ global alignment
• Zeiss and rest equipement troubleshooting for NCHS/ Sudtor
• Drive the standanization of cross-functional QC

【Required Skills & Qualifications】

1. Bachelor's degree in Engineering, Quality Assurance/Control, or related field
2. 3+ years of experience in quality control, preferably in manufacturing
3. Strong knowledge of quality control methodologies and tools (e.g., SPC, 5S, Six Sigma)
4. Familiarity with quality management systems (e.g., ISO 9001, ISO13485, FDA)
5. Proficient in using quality control software and Microsoft Office Suite
6. Excellent analytical and problem-solving skills
7. Strong communication and interpersonal skills
8. Ability to work independently and as part of a team
9. Attention to detail and commitment to high-quality standards
10. Upper-intermediate to advanced English proficiency (both written and spoken)