Senior Quality Assurance Engineer

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Medical Devices organization, based in Limburg Netherlands.

is occupied with the development of medical accessory innovations, development, manufacturing, and commercialization of Medical Devices. The Medical accessories are marketed worldwide through our network of OEM’s and specialized distributors.

ROLE DESCRIPTION

You will be the most senior professional within this company in the field of QA. You will be the knowledge buffer in the QA, both EU and FDA regulations. In this company projects will be realized turn key, so knowledge of Development QA and Manufacturing QA are essential. The role will ask a pragmatic attitude, intrinsically motivated to work in a close-knit multidisciplinary team towards improving process efficiency while maintaining the high quality standard required for the realization of the clients products.

RESPONSIBILITIES

• Maintaining ISO 13485 and FDA 21 CFR Part 820 related QA system, processes and procedures
• Planning and conducting quality system related trending and reporting
• Providing guidance and support in managing change controls, CAPAs and life cycle management of documents
• Supporting in filing submissions to FDA, Notified bodies, Competent Authorities and Ethical Committees for Medical Devices
• Conducting internal and supplier audits
• Providing support for the teams based in the US and Indonesia in respect to compliance with internal and external RA/QA requirements
• Supervising activities in document control and release activities
• Act as backup for Senior Regulatory and Quality Manager

REQUIREMENTS

• An engineering degree, preferably in biomedical engineering, or similar education level
• Minimum of 5 years work experience in medical device or pharmaceutical industry or equivalent, minimum 3 in quality-related functions
• In-depth understanding on quality systems and regulated processes, esp. according to ISO 13485, MDD 93/42/EEC and 21 CFR 820
• Experience in internal audits and quality system audits by Notified Bodies
• Ability to understand processes and identify critical gaps and areas for improvement
• Experience in supplier quality management
• Experience with people management preferred
• Certified as auditor a plus
• Experience in clean room work environment a plus
• Ability to communicate, train and provide guidance
• Fluent in English and Dutch

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Tim Thuijs.