QA - Customer Quality Engineer

2 days ago

Taoyuan City Taoyuan City, Taiwan SHL Medical Full time $70,000 - $120,000 per year

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 responsible area includes complaint handling process with customers, root cause investigation for product quality complaint, regulatory concern in critical quality event, post-market data analysis, and quality system activities. This position works closely with internal and external stakeholders to identify/ drive improvement initiatives in whole product lifecycle and quality management system so to ensure continuous product safety and effectiveness on the market.

Main Responsibilities

  • Serve as company liaison with foreign customers and deliver outstanding customer service to resolve product quality complaints
  • Analyze complaint failure modes according to complaint descriptions, evaluation on returned defect samples, manufacturing records, and design history records
  • Complete technical investigation and root cause analysis with cross functional team members ‧ Issue corrective and preventive action (CAPA) and verify the effectiveness of CAPA
  • Compose and submit a detailed and high quality report for the root cause investigation
  • Ability to effectively communicate and interact with foreign customers, team members, and various technical disciplines covering end-to-end product lifecycle (e.g. mechanical design, injection molding, plastics, metal, assembly, functional testing)
  • Periodically complaint data analysis to identify actionable insights and continuous improvement for product/ process, and present complaint statistics to customers and management.
  • Establish and maintain complaint investigation method and provide training to customer's complaint handling center when required.

Minimum Qualifications

  • Bachelor or above degree in science or engineering background (e.g., mechanical, industrial engineering, biomedical, chemical engineering, material/life science)
  • Logical thinking and proficient problem-solving skills
  • Fluent English in speaking and writing with strong organizational and communication skills
  • Ability as a team player to frequently cooperate with cross-function team members in different ways (e.g., phone call/meeting/e-mail)
  • Time management ability to complete assigned jobs in a timely manner
  • Good flexibility/anti-stress ability to deal with different/urgent issues

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.

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