Supplier Quality Engineer
3 months ago
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.
Travel Percentage: 10%-
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