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Senior Analyst Quality
Job Description
Job Summary:
This role is responsible to review and to approve of Medical device Verification and Validation documentation. As the Quality Assurance approver, this role works closely with the software and Hardware development teams to assure procedural and regulatory requirements are met.
Essential Duties and Responsibilities:
- Documents preparation, verification & maintenance of Quality management system as per ISO 13485.
- Preparation, updating & maintenance of all QMS documents and ensuring the compliance as per ISO 13485.
- Conducting Internal audit & MRM as per ISO 13485
- Control on suppliers/contract manufacturer as per SOP
- SOP preparation, verification and issuing to all departments.
- Updating change control records
- Updating design documents & risk management file as per ISO 13485 requirements.
- Root- cause analysis for product related & process related nonconformities and find the corrective action for the same.
- Customer complaints verification & documents updating as per SOP
- Training documents preparation & analysis of training effectiveness as per SOP
- Product & process validation.
- Preparation, verification & maintenance of various documents like device master file , site master file , technical file as per requirements of various countries regulatory body.
- Preparation of documents for registration in various countries according to their regulatory requirements.
- External audit handling – coordination with auditors, NC Closing, CAPA implementation etc.
Requirements
Basic Qualifications:
- Education: Requires Bachelor’s degree in science related field.
- Experience: 5-10 years in Medical Device Industry
Preferred Knowledge, Skills and Abilities:
- Good understanding of Software Development in Pharma/ Medical Device Industry.
- Ability to work in a team environment. Ability to work independently with minimal supervision
- Motivated and willing to learn
- Working knowledge of cGMP requirements for process , software and hardware
Travel Requirements:
- Travel 10-35%
About us
West Taiwan is a Digital Technology Center of West Pharmaceutical Services, Inc., dedicated to exploring and utilizing leading-edge software development technologies to build high-quality software. Current and future development projects involve industrial production and automation, medical monitoring and analysis, smart medical devices, healthcare data exchange system and IoT for hospitals. With an international team of more than 40 software engineers in Taiwan and Taichung, we have developed a broad scope of technological expertise including machine-learning, mapping systems, cloud infrastructure, highly scalable clusters, infrastructure-as-a-code and testing automation.
Our parent company, West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply.
West is a listed company in NYSE and named to the S&P 500 Index in 2020. Headquartered in Exton, Pennsylvania, it supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2019 net sales of $1.84 billion reflect the daily use of approximately 100 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.
In 1983, West established operations in Singapore in the Asia Pacific region. In 2009, an injection molding facility opened in Shanghai Qingpu Industrial Zone in China. At present, West has two digital technology centers in Bengaluru India and Taiwan China, three main production bases located in Singapore, Shanghai China and Chennai India, and seven offices and distributor centers in Australia, China, India, Korea, and Singapore. Globally, West has about 50 locations with 25 manufacturing facilities
Join us and be part of the journey of the digital revolution!
