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Sr. Engineer, Supplier Quality

Employer
Integra LifeSciences
Location
Columbia, MD
Closing date
Jun 24, 2022

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  • Provides quality assurance leadership to select contract manufacturing sites and raw material suppliers
  • Establishes and ensures the Approved Supplier List is up to date
  • Establishes the yearly supplier's audit planning and ensures the execution in a compliant manner
  • Conducts supplier audits according to good manufacturing practices, international organization for standardization and any other applicable standards
  • Ensures comprehensive measurement systems in place to monitor effectiveness of supplier quality and reliability systems to identify, correct and prevent defects
  • Establish and ensure Supplier Quality Agreements are up to date for applicable suppliers
  • 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 Request compliance with procedures and regulatory requirements
  • Ensures that activities for validation of outsourced new processes/products are performed and documented according to procedures and within the defined timeline
  • Addresses and corrects outsourced product and processes non conformances
  • Ensures that Supplier Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
  • Escalate supplier quality issues and make sure that appropriate actions are in place to fix the issue in a compliant manner
  • Participates and supports internal and third party audits / inspections
  • Conducts internal audit if required
  • Manages or participates on quality projects
  • Provides support to complaint investigation if required
  • Participates to procedure elaboration or update
  • Ensures support to process improvement projects


  • A minimum of a Bachelor's Degree is required. A degree in Engineering, Life Science, or a related technical discipline.
  • Experience working in a Medical Device manufacturing environment is preferred.
  • Operations supplier quality experience is preferred
  • Minimum 4 years of professional work experience in a GMP and /or ISO regulated industry is required
  • Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR part 820
  • Strong communication, teamwork, and organizational skills
  • Strong analytical problem solving and root cause analysis skills
  • Auditing background is required
  • Use of ERP, PLM systems
  • Use of Microsoft office tools
  • Knowledge of statistical techniques
  • Experience or knowledge with abattoirs is preferred


In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.
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