Testing - Verification Document Specialist (Contractor)

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.

瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。

Job Overview

The Verification Doc Specialist is responsible for ensuring the precision, accuracy, and compliance of data, transactions, and documentation with industry standards and regulations by examining their authenticity. This pivotal role involves a meticulous review of information, seamless coordination with various departments, and leveraging advanced verification tools to uphold the integrity and trustworthiness of organizational outputs.

Main Responsibilities

• Prepare various documents such as test protocols and test reports for design assessment and design verification activities, ensuring compliance with QMS requirements and standards or guidelines related to medical verification activities (e.g., ISO 11608 series, ASTM, FDA CFR 820, etc.) as well as adherence to Good Documentation Practice (GDP). 
• Perform data analysis which includes test data and design verification results, and provide statistical technical support and analysis results explanations.
• Generate professional and impactful technical writing that meets the diverse requirements of organizational activities.
• Independently review, edit, and organize documents to ensure clarity, logical flow, accuracy, and completeness, while ensuring proper classification, filing, and storage in accordance with company policies.
• Manage and track test material requests for Verification Engineers, ensuring timely approvals and delivery to facilitate the smooth execution of testing activities.
• Provide expertise and support to department members on company processes, systems, and documentation-related issues.
• Coordinate and support departmental training and development initiatives, with responsibilities that may include planning, communication, or session delivery as needed.

Minimum Qualifications

• Bachelor's degree (preferably in a STEM field)
• TOEIC score of 800 or above (or equivalent, such as TOEFL, IELTS, or other internationally recognized certifications)
• Strong English verbal and written communication skills
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• Skilled in performing detail-oriented tasks with high accuracy
• Strong organizational and systematic skills, with the ability to structure and manage information effectively
• Collaborative with strong interpersonal skills and effective at facilitating cross-departmental communication
• Ability to complete milestones and work toward multiple deadlines simultaneously
• Patient and persistent, with the ability to handle and large volumes of information 
• Knowledge of Good Documentation Practice (GDP)

Preferred Qualifications

• Practical experience in writing and managing medical device verification documentation.
• Proficiency in Data Analysis and Statistical Tools (e.g., Minitab)
• Strong problem-solving and analytical thinking skills

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.