Quality Engineer to BONESUPPORT!

About the role

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.

You will join a dedicated Operations team in Lund that manages the entire supply chain, from procurement and production planning to final approval. While you will work closely with your fellow Quality Engineers, you will also be a key partner to the Senior Manufacturing Engineer, assisting with equipment control and technical validation. This is a group characterized by a high level of expertise, a supportive atmosphere, and a strong sense of community. Working closely with your peers, you will ensure a smooth flow of information and contribute to a positive, collaborative team dynamic.

You are offered

• 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.

Work tasks

Your focus is to ensure that production processes and equipment meet the highest standards of quality. You will balance daily operational quality control with technical projects in close collaboration with the Senior Manufacturing Engineer. To achieve this, your key responsibilities will include:

• 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.

We are looking for

• A 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.

It is meritorious if you have

• 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.

To succeed in the role, your personal skills are:

• Supportive
• Goal oriented
• Orderly
• Responsible
• Assertive

Other information

• Start: Asap/ Upon agreement
• Work extent: Fulltime, 40h/week
• Location: HQ in Lund

Our recruitment process

This recruitment process is handled by Academic Work and it is our client’s wish that all questions regarding the position is directed to Academic Work.

Our selection process is continuous and the advert may close before the recruitment process is completed if we have moved forward to the next phase. The process includes two tests: one personality test and one cognitive test. The tests are tools to find the right talent for the right position, to enable equality, diversity, and a fair process.

Bonesupport

BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CREAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. Bonesupport has around 170 employees and almost half of them are based in Lund at the company headquarters.

BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB