Supplier Quality Engineer
Date de publication :
03 octobre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Lund
Supplier Quality Engineer
Join the Stryker/Jolife AB team in Lund, where we develop and manufacture the LUCAS chest compression system, a life-saving medical device invented in Lund and used worldwide to treat sudden cardiac arrest patients. As a Supplier Quality Engineer, you will manage and coordinate projects and activities related to supplier and production quality.
Key Responsibilities:
- Manage and coordinate projects and activities related to supplier and production quality.
- Collaborate closely with suppliers and contract manufacturers on quality issues.
- Manage the issuance, distribution, and resolution of non-conformities.
- Act as a Subject Matter Expert in CAPA investigations.
- Review and follow up on supplier quality assurance activities, including production and process qualification, as well as validation.
- Conduct supplier audits and coordinate the closure of non-conformities identified during audits.
- Prepare and analyze quality system and supplier-related data to identify areas for improvement.
- Participate in supplier approvals and re-evaluations.
- Perform gap analysis for new or updated regulatory and company requirements within your area of expertise.
- Support the maintenance and continuous improvement of Jolife’s Quality Management System (QMS).
Opportunities & Benefits:
- Contribute to the development of life-saving emergency care solutions.
- Engage in fulfilling cross-functional activities with colleagues locally and internationally.
- Help shape the future of the LUCAS device to ensure world-class products.
- Work in one of Europe’s "Top 7 Great Places to Work."
- Attractive flexibility in working arrangements.
Is this you?
- You hold a university degree in natural sciences, medicine, pharmacy, engineering, or a related field.
- You have at least 5 years of experience in quality engineering, manufacturing, or R&D, with 3 years of professional experience in Quality Management Systems or Regulatory Affairs related to medical devices.
- You have expertise in ISO 13485 and national regulatory requirements for medical devices, as well as experience in quality audit techniques (ISO 19011 or equivalent).
- You have experience working closely with manufacturing facilities to ensure quality.
- You possess excellent communication skills, strong attention to detail, and the ability to manage multiple tasks simultaneously.
- You adapt quickly to new challenges and have strong problem-solving and analytical skills.
About Stryker and Jolife AB:
Jolife AB, a wholly-owned subsidiary of Stryker, develops and markets the LUCAS™ Chest Compression System, a Swedish breakthrough innovation for mechanical chest compressions used during cardiopulmonary resuscitation (CPR). Stryker is a global leader in medical technologies, impacting over 130 million patients annually with innovative products and services in MedSurg, Neurotechnology, Orthopaedics, and Spine. For more information, visit stryker.com.