SUPPLIER QUALITY ENGINEER
- Göteborg
- Pågående
MAIN TASKS AND RESPONSIBILITIES
As a Supplier Quality Engineer (SQE) at XVIVO, you’ll play a vital role in ensuring the quality and reliability of the products we supply. You will collaborate with our global team, working mainly with suppliers in Sweden and Europe, to evaluate, approve, and monitor suppliers in accordance with XVIVO’s requirements, quality standards, and regulations.
Your responsibilities will include:
- Developing processes to obtain high quality and economically competitive products
- Support transfer of design to production, in- or outsourced, including assembly and test instructions
- Qualification and validation of production equipment, production processes and clean room
- Maintaining and develop QMS processes related to production and process validation
- Establishing control plans of purchased material
- Supplier related non-conformities and SCARs
- Monitoring supplier performance and KPI’s, and initiating necessary actions
- Conducting CAPA, FMEA, and other failure investigation activities related to suppliers
- Leading supplier risk assessments and quality complaints meetings
- Providing support to suppliers regarding materials and components quality
- Collaborating on continuous improvement programs with suppliers and monitoring manufacturing capabilities
REQUIREMENTS
- Experience as a Supplier Quality Engineer or Quality Engineer
- Experience working within a QMS (Quality Management System) (process ownership beneficial)
- Proficiency in process validation, lean manufacturing, and risk analysis
- Excellent interpersonal, communication, facilitation, and team working skills
- University degree within relevant area
- Excellent communication skills (written and spoken) in English (proficiency in Swedish is beneficial)
- Willingness to travel to interact with global team members and external partners
Additionally, we are looking for someone who is:
- Experienced within microbiology and/or sterilization
- Familiar with regulatory and quality standards such as MDR, FDA, ISO13485, ISO14971 etc.
Why join XVIVO?
At XVIVO, we are more than just a workplace; we are a community of engaged individuals committed to making a difference in the world. As a company, our vision guides our work, and our core values serve as the guiding principles that define our culture. Join us on a journey where innovation and research meet impact, and every team member plays a crucial role in shaping XVIVO’s future. We Believe in an Extended Life for Organs. Nobody Should Die Waiting for a New Organ
Our core values: Customer Centric, Research Driven, Purposeful, Collaborative
To apply:
In this recruitment we collaborate with Moveup Consulting AB. Please send your application to tom.bergqvist@moveup.se For more information about XVIVO, and the role please contact Tom Bergqvist at 0733-87 27 22.
By submitting your application, you also give your consent to storing your personal information, including CV & Cover letter, and that we own the right to share this information with third parties (our client). You can withdraw yout consent at any time.
XVIVO is a medical technology company listed on the Nasdaq Stockholm exchange, with headquarters in Mölndal, Sweden, a production site in Lund, Sweden, offices in USA, Italy, and the Netherlands. The company is firmly rooted in medical science with its core business in organ transplantation. XVIVO is the first in the world to offer both machines and consumables for all major solid organs. We are committed to bringing innovative technology for storage, evaluation, and treatment of organs to transplant centers around the world, enabling the safe use of more donated organs and ultimately giving more patients the chance of a life-saving transplant.
Company culture
The culture of XVIVO is the culture of a small company with high growth ambitions based on the foundation of a common belief that patient safety, our vision – “Nobody should die waiting for a new organ”, is key for our success. We strongly believe in the fact that nothing is impossible and thrive to get the job done. We, no matter which position or work description, are always focused on helping our customers.
