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

This position is to provide quality oversight to assure design, development, manufacturing and post-market of SHL product are compliant to applicable regulations, standards, and SOPs. QA engineer ensures the delivery of high quality product which meet the regulatory requirements and customer expectations.

Main Responsibilities

• Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team.
• Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement.
• Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process.
• Present accumulated quality data to customers and management.
• Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues.
• Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines.
• Support external quality inspections and execute internal and supplier audits.
• Complete assigned tasks on time with minimal supervision (self-motivated).

Minimum Qualifications

• BS degree above or equivalent technical work experience.
• Clear / logical thinking with strong organization and communication skills
• Proficient problem solving skills.
• Working knowledge of Microsoft Office.

Preferred Qualifications

• Experience in the medical device industry is preferred.
• Knowledge of regulatory compliance: GMP (good manufacturing practice), QSR (quality system regulations), and ISO 13485 is preferred.
• CQT (certified quality technician), CQE (certified quality engineer) is a plus.
• Six sigma green belt or black belt is a plus.

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.