QA - (Senior) Audit 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

To support risk-based approach audit events including audit preparation, audit awareness training and verify effectiveness of CAPA process.

Main Responsibilities

• Responsible for audit preparation, coordinating and organizing internal/external audits
• Assist in development of audit plan, audit schedules, audit report and follow-up audit findings till closure
• Support the site corrective and preventive actions process
• Collect & analyses data analysis for internal/external audit performance
• Training employees on GxP and quality standards and procedure to ensure audit readiness
• Maintaining documentations and procedures within the QMS
• Keep abreast of industry standards and regulations
• Carry out other duties as assigned by the supervisor or management.

Minimum Qualifications

• Bachelor’s Degree in Engineering, manufacturing ,technical discipline, other related science is required.
• 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

• 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.
• Minimum 3 years’ experience in Quality Assurance related function, Medical Device, Bio-Pharmaceutical or other regulated industry.
• 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.