Supplier Quality Engineer

Job title:

Supplier Quality Engineer

Company

Stryker

Job description

Work Flexibility: Hybrid or OnsiteSupplier Quality EngineerJoin 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%

Expected salary

Location

Lund, Skåne

Job date

Thu, 03 Oct 2024 23:48:54 GMT

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