Quality Assurance Specialist/ Quality Engineer / QA-Specialist

Om Bravura:

Bravura är ett bemannings- och rekryteringsföretag för organisationer som vill hitta Next Gen Professionals. Hos oss finns massor av jobbmöjligheter, framförallt för dig i början av karriären med 0-8 års erfarenhet. Via oss kan du jobba som konsult eller bli rekryterad. Hitta ditt drömjobb - vi hjälper dig att lyckas!

Om kunden:

About the company

Triomed AB is a medical technology company in Lund that develops systems for patients with kidney and heart failure. The systems are based on proprietary technologies and will improve the quality of life for kidney and heart disease around the world.
Triomed, which today has 13 employees now wants to strengthen its organization with a hands-on and pragmatic Quality and Regulatory Manager.

Arbetsuppgifter:

Work Tasks:
As a QA-Specialist you will be a key member of the product development team. You will support the development of the Design History File, both producing and/or reviewing the following types of documents:

• User needs
• Design specification
• Risk Management File
• Test protocols
• Test reports
• Study reports

You will also be expected to provide input into the development and maintenance of Triomed’s QMS. Preparing and reviewing SOPS, performing internal and external audits, and supporting the management review process.

Profil:

Education, Experience, Personal Characteristics, and other Requirements:
Required Skills
• BSc or MSc in science or engineering
• 4+ year’s experience of QA related work from a regulated industry
• Experience of document review and document control
• Excellent verbal and written communication and presentation skills in English

Desired Skills
• Quality System Regulation (QS regulation) - 21 CFR Part 820
• ISO 13485
• Risk management and risk analysis – ISO 14971

You are team player who enjoys working withincross functional team with people of different cultures and experiences. You canwork independently, have strong problem solving, communication, analytical skills, and an attention to detail. You are also openminded and can swiftly shift your focus when the expectations and priorities changes. For the right person this role will provide the opportunity to take a high level of responsibility quickly.
open-minded and can quickly shift your focus when priorities change.

Övrig information:

Other information:
Start: As agreed upon
Placement: Lund
Salary: According to agreement

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Vi rekommenderar att du skickar in din ansökan omgående då vi gör ett löpande urval. Välkommen med din ansökan!

Sökord: QA, RA, Manager, MedTech, QMS, FDA, QSR, ISO, Medical Device, Pharmaceutical, QA/RA, Science, Engineering, Lund, Medicinteknik, Quality Engineer, QA-Specialist, Quality Assurance Specialist