*** DET(Development Emerging Technologies) QARA team will expand in 2024! Welcome all the potential candidates join us. ***
About Us
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 United States.
Job Overview
The Supplier Quality 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
Main Responsibilities
- Direct supplier qualification in accordance with outsourced material and part qualification system requirements specifications
- Benchmark existing manufacturing supplier management procedure to establish and maintain supplier management activities for design and development teams
- Work hand-in-hand with quality engineering team to establish critical-to-quality, acceptance criteria and testing requirements to outsourced suppliers
- Develop Supplier Quality Agreement
- Categorize the new supplier according to the procedure
- Perform periodic supplier evaluation
- Assist in sourcing, and assessing suppliers to supply the necessary material
- Support the evaluation of supplier's performance and supplier's continuous improvement program
- Visit supplier's facilities and observe the manufacturing environment to review and assess their procedures
- Co-ordinate incoming tests and assessment on outsourced material and purchased component to verify quality requirements are met
- Maintaining detailed reports on supplier quality, including defect rates and area for improvements
- Providing technical advice and guidance to suppliers to reduce defect rates
- Responsible for supplier audit including preparation, coordinating and assist in internal/external audits. Specialty:
- 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
- Review and approves supplier failure analysis relative to corrective action provided and coordinate resolution of quality assurance related problems
- Assign above job tasks by staffing qualification / personal ability / organization needs
- Carry out other duties as assigned.
Required Skills & Qualifications
- Bachelor's Degree in engineering, science, or logistics, medical technology or other related science is required
- Minimum 2 years experience in supplier management processes and engineering principles.
- Familiar with ISO 9001 or ISO 13485 and ISO 14971 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 in English and Mandarin
