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 Unites States.

【Job Overview】

The Supplier QA Audit Engineer is responsible (a) To drive supplier quality performance, including new product development and product quality improvement (b) Overseeing supplier quality team and establishing quality control objectives (c) Ensuring the supplier regulatory and company requirements (d) Performing quality system audits and development good partnership with suppliers

【Your responsibilities】

1. Responsible for suplier audit including preparation, coordinating and assist in internal/external audits. Speficality:

• Development of audit plan, audit schedules, audit report and follow-up audit findings

• Perform data analysis for supplier audit performance

• Keep abreast of industry standards and regulations

2. Responsible to evaluate supplier’s performance and drive supplier’s continous improvement program

3. Assist in sourcing, and assessing suppliers to supply the necessary material

4. Visiting supplier’s facilities and observing the manufacturing environment to review and assess their procedures.

5. Review and approves supplier failure analysis relative to corrective action provided and coordinate resolution of quality assurance related problems.

6. Reviewing incoming supplies and in-process products from vendors to check for defects and ensure quality.

7. Conducting tests and assessment on product to identify quality issues.

8. Matntaining detailed reports on supplier quality, including defect rates and area for improvements

9. Providing technical advice and guidance to suppliers to reduce defect rates

10. Assign above job tasks by staffing qualification / personal ability / organization needs.

11. Carry out other duties as assigned.

【Skills and Qualification】

• Bachelor’s Degree in engineering, science, or logistics, medical technology or other related science is required

• Minimum 2 years’ experience in manufacturing and production processes and engineering principles.

• Familiar with ISO 9001 or ISO 13485 is preferred

• Good working knowledge of quality control standards and government compliance.

• Ability to analyze data and apply statistical techniques in order to improve process efficiency

• Able to work well in a team and manage your own job load independently

• Good interpersonal, written and verbal communication skills

We Offer

•An exciting opportunity in a fast-growing international medical device comany

•A modern working environment, with multicultural and dynamic teams

•Flexible working hours and a hybrid remote work policy