QA Supervisor Medical Devices
SIRE Life Sciences®
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SIRE® 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.
The CompanyQuality supervisors manages and implements the company’s quality assurance and control systems to ensure proper execution of products and customer satisfaction and so contributes to the growth and profitability of the company.
Role Description• Implementation of the Quality Management System– CAPA/Deviations/Internal Audits/Complaints – in line with procedures and regulatory requirements
• Lead and develop the Quality Team within the site, communicate expectations clearly and ensure staff is appropriately trained
• Quality metric reporting and trending, with escalation of quality issues to senior management team
• Complete quality investigation and product risk assessment for product disposition
• Provide leadership in change management and risk assessment
• Conduct, lead, or direct product complaint investigations
• Facilitate and support external audits
• Conduct and implementation of the internal Audit programme
• As part of the management team, support and execute cost of quality and project improvement initiates
• Ensure team is trained to FDA QSR, ISO 13485 / 14971 and MDSAP requirements
Responsibilities• Personnel Staffing and Management
• Problem Solving and Analyzing
• Attention to detail
• Change management
• Goal Setting
• Processes Improvement
• Project Managing (includes AFE process)
• Fiscal Managing (includes budget preparation)
Requirements• 5-7 years quality experience, including previous supervisory experience.
• B.S. or B.A. in Physical Science, Engineering, or other related discipline
• Knowledge of applicable foreign and domestic regulations
• Knowledge of quality auditing techniques
• Knowledge of process validation techniques
• Knowledge of resource planning
• Knowledge of project management skills
• Strong technical writing skills and attention to detail
• Ability to speak, read and write in English & Dutch
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Fernand Voortjes.