Supplier Quality Engineer

Integra Lifesciences Switzerland SAS
Le Locle

2T

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”

Supplier Quality Engineer

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”

  • Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers engaged in the production of Integra products
  • Establishes and ensures the Approved Supplier List is up to date
  • Establishes timely planning and execution of supplier audits
  • Conducts Supplier Audits according to good manufacturing practices, ISO Standards, and applicable regulatory requirements
  • Ensures comprehensive measurement systems in place to monitor supplier quality/reliability, and to identify, correct and prevent defects
  • Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers engaged in the production of Integra products
  • Report on contract manufacturer performance metrics
  • Ensure technical support to QC, purchasing and production departments
  • Provide Quality Engineering Support to suppliers including audits/assessments, inspection technique support, verification /validation activities, CAPA and change management. FDA CFR part 820 and ISO 13485 regulations/standards will be the focus.
  • Addresses Supplier Change Requests in compliance with procedures and regulatory requirements
  • Ensures that activities for validation of outsourced processes/products are performed and documented according to procedures and within the defined timeline
  • Participates in and leads continuous improvement projects and initiatives
  • Ensures that Supplier Non-conformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
  • Escalate supplier quality issues to management as appropriate, develop and propose robust and compliant solutions
  • Participates and supports internal and third party audits / inspections
  • Conducts internal audit as required
  • Manages or participates in quality projects as required
  • Provides support with complaint investigations as required