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Stryker
Lund, NA, Sweden
14 days ago
Stryker
Lund, Sweden
14 days ago

Description

About Stryker
Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Responsibilities
  • Maintenance and continuous improvements of the Jolife Quality Management System.
  • Performing gap analysis for new or updated regulatory requirements and execute actions to assure compliance.
  • Manage and coordinate projects and activities relating to the Quality Management System.
  • Manage the issuing, distribution and completion of non-conformities.
  • Act as a Subject Matter Expert in CAPA investigations
  • Review and follow up on supplier's quality assurance activities, e.g. Production and process qualification including validation.
  • Follow up of quality audits and coordinate the closure of findings.
  • Prepare and analyze quality system and supplier related data.


Authorities
  • All responsibilities automatically include the authority to perform the responsibility.


Competence Requirements
  • University degree (or of an equivalent course of study) in natural sciences, medicine, pharmacy, engineering, or another relevant discipline,
  • 7+ years of experience in Quality engineering/manufacturing/R&D or equivalent whereof 5 years professional experience in Quality Management Systems and/or Regulatory Affairs relating to medical devices.
  • Expertise in current Quality Management System standards, i.e. ISO 13485 and documented knowledge in national regulatory requirements for Medical devices
  • Quality Audit Techniques (ISO 19011 or equivalent) and Supplier Controls
  • Experience of Electronic Document Handling Systems is meriting.
  • Statistical techniques for Quality Data

Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program.

Job Information

  • Job ID: 57840514
  • Location:
    Lund, Sweden
  • Position Title: Senior Lead Quality Engineer
  • Company Name: Stryker
  • Job Function: Engineering
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