Quality Assurance Manager
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands.
• Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
• Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
• Create quality function deliverables as per Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
• Review Requirements Management process and outcome.
• Reviews Product Verification and Validation.
• Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
• Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
• Ensures timely execution and required communications and escalation.
• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Preferably experience in a medical device industry.
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project
• Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
• Both detail oriented and able to see big picture
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.
Role Description
You will be part of the Q&R team consisting of approximately 30 team members working for the several departments. You will work in project teams with co-ordination with marketing teams, manufacturing teams at various sites, supplier teams, and other Q&R members across our client.Responsibilities
• Instruct, coach and facilitate project teams in Quality Management System (Procedures/ Policies/ Guidelines/ tools/ training, etc.).• Instruct, coach and facilitate project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
• Drives and supports quality & regulatory compliance to assure products & services comply with the Quality Management System / Business Management System requirements
• Create quality function deliverables as per Quality Management System in projects, in Life Cycle Management and in Post Market Surveillance.
• Review Requirements Management process and outcome.
• Reviews Product Verification and Validation.
• Ensure Risk Management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
• Ensure compliance to quality system requirements, regulations and standards in designated area of responsibility.
• Ensures timely execution and required communications and escalation.
Requirements
• Bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.• Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
• Preferably experience in a medical device industry.
• Proven ability to successfully incorporate and manage stakeholder needs throughout a project
• Communicate globally, across teams and programs, from senior executives to administrative support personnel. Experience leading remote teams.
• Both detail oriented and able to see big picture
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rowin van der Zwaan.
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