Quality Assurance Specialist
BioSystems designs, develops, manufactures, and markets analytical solutions, devising both reagent tests and analytical instrumentation for in vitro diagnostic (IVD) laboratories as well as for industrial purposes. Our aim is to improve health and well-being around the world.
To achieve this, we develop solutions based on the One Health concept for Clinical analysis, Veterinary analysis, Food & Beverage analysis, Environmental analysis, and Bioprocess analysis.
We are a global company, serving over 100 markets through distributor partnerships and with own centers in 16 countries. This allows us to be close to our solution users, providing the best possible customer care and ensuring our technical service reaches customers worldwide.
We look for a person with customer service orientation, analytical skills, proactive, autonomous, decisive, goal-oriented, who likes teamwork, and has a great ability to adapt to change.
Responsibilities:
1. Work in the Quality Assurance - Regulatory Affairs Department, in a company with a Quality Management System certified under ISO 9001 and ISO 13485 and IVD Regulation compliant, helping to maintain and improve this Quality System.
2. Implement new Regulations/Standards applicable to our Quality Management System.
3. Get involved with all the processes and prepare and maintain related procedures.
4. Plan and document computer systems validation activities, according to international standards (ISPE GAMP5, ISO 80002-2, etc.).
Requirements:
1. High education in biosciences and regulatory matters.
2. Experience in Quality Management Systems.
3. Knowledge of MD or IVD European Regulation (UE 2017/745 or 2017/746) and ISO 13485.
4. High adaptability to changes and constant evolution.
5. Fluent English.
We will value experience in computer systems validation (ERP, eQMS) and knowledge of international standards on computer systems validation (ISPE GAMP5, ISO 80002-2) and SAP S4HANA skills.
We offer:
1. Flexible schedule, 39 hours per week
2. Location: Barcelona, Sant Andreu district
3. Immediate start
4. Company environment that encourages innovation, teamwork, personal and professional growth
5. Permanent contract
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