Quality Engineer Jobb | Academic Work (Lund)

Quality Engineer

Academic Work

Plats:
Sweden , Lund

Kategori:
Tillverkning

Kontrakttyp:
Ej angivet

Lön:

Ej angivet

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Jobbbeskrivning:

As a Quality Engineer at BONESUPPORT, you will serve as the vital technical bridge between regulatory requirements and hands-on production. Embedded within the Operations team, you will work in close collaboration with Quality Management, R&D, and external suppliers. Your mission is to ensure that all processes remain stable, secure, and documented to the highest industry standards. This role is uniquely positioned to bridge the gap between pure quality documentation and technical equipment management, meaning you will have a more technical and hands-on focus on the machinery and validation processes.

Jobbansvar:

Manage equipment control: Take ownership of the Master Validation Plan (MVP) and the equipment list. This involves creating User Requirement Specifications (URS), writing and executing protocols, performing tests (validation/qualification), and ensuring the ongoing control of validated status for all machinery and lab equipment
Support Design Transfers: Act as the 'receiver' in projects when new products or design changes move from R&D to production. You ensure that all documentation is complete and take an active role in building Device Master Records (DMR)
Quality Operations: Review batch documentation and manage deviations, CAPAs, and Change Orders. You investigate technical issues in production and help find long-term solutions
Supplier Contact: You will maintain an ongoing dialogue with suppliers in Sweden and Poland regarding technical status, component quality, and machinery/equipment standards

Krav:

University degree (B.Sc. or M.Sc.) in Mechanical Engineering, Biomedical Engineering, Chemical Engineering, or a similar technical field
A genuine interest in technology and an understanding of how machinery and equipment are built and operated
Excellent English skills, as you will handle documentation and communication in English daily

Önskvärt:

Project Experience: Experience working in project teams, understanding your role as a technical contributor and delivering against specific deadlines
Quality & Validation: Previous experience from a regulated industry (MedTech, Pharma, or similar) or specific training in Qualification/Validation (writing, executing, or approving documentation)
Design Transfer: Experience acting as a receiver in projects involving new product introductions or supplier transitions
Proficiency in Swedish is a plus for local collaboration, but not a requirement

Vad vi erbjuder:

No boredom! BONESUPPORT is a stimulating and fast-growing workplace where you are challenged and developed daily
Meaningful Technology: Work with products based on a scientifically trustworthy foundation that truly changes patients' lives
International Environment: A global arena with colleagues in Sweden, Germany, the UK, and the US
Development: Great opportunities for internal rotation and career growth as the organization continues to expand

Ytterligare information:

Jobb publicerat:
02 mars 2026

Anställningstyp:

Heltid

Arbetstyp:

Arbete på plats

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