QA - Supplier QA Engineer

About SHL Medical
SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues.

Job Overview
The Supplier QA Engineer is responsible for

• To drive supplier quality performance, including new product development and product quality improvement
• Overseeing supplier quality and establishing quality control objectives
• Ensuring the supplier fulfill regulatory and SHL's requirements
• Performing quality system audits and development good partnership with suppliers

Main Responsibilities

• Ability to manage the quality of products and services provided by suppliers, ensuring compliance with company standards and requirements. Independently conduct investigations on abnormalities, analyze potential process risks, identify root causes, and drive improvements to continuously enhance supplier quality performance.
• Experience in planning and executing supplier evaluations and audits, including document reviews and on-site inspections. Coordinate and support second-party and third-party certification audits. Evaluate supplier responses to deficiencies and lead supplier quality improvement initiatives.
• Familiarity with quality management systems and relevant standards (e.g., SOPs, GMP). Capable of developing and maintaining quality documents and training programs. Provide quality and GxP training to internal teams and suppliers to ensure audit readiness.
• Skilled in data analysis to drive continuous improvement projects aligned with departmental and company goals.
• Strong communication and coordination skills to effectively collaborate with cross-functional teams and suppliers, resolve quality issues, and report quality status and audit findings to senior management.

Minimum Qualifications

• Bachelor's Degree in Engineering, manufacturing ,technical discipline, other related science is required.
• Minimum 3 years' experience in Quality Assurance related function, Medical Device, Bio-Pharmaceutical or other regulated industry.
• Trained internal auditor in ISO 13485 / ISO 9001 or equivalent will be an added advantage.
• Experience in managing external quality audit will be an added advantage.
• Able to work well in a cross functional team and manage your own job load independently.
• Well-versed in English and Chinese, read, written and communicate.
• Attention to details, keen interest in compliance and continual improvement matters.

Preferred Qualifications

• Familiar with 21 CFR 820, ISO13485, cGMP is preferred.
• Knowledge of Quality Tools, auditing technique, problem solving skills is preferred.

We Offer

• Challenging assignments in a fast-growing and innovative industry.
• A multicultural team and modern working environment with state-of-the-art facilities and technologies.
• A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
• Various opportunities for personal and professional development within a global organization.
• Flexible hours and hybrid working policy.