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Sr. Manager, Supplier Quality Engineering

Company: Integra LifeSciences
Location: Mansfield
Posted on: July 23, 2021

Job Description:

  • Responsible for Supplier Quality actvities within the CSS division, managing staff across multiple sites
  • Serves as a key point of contact to Quality and Supply Chain partners for Supplier Quality issues, and liaises with the Integra organization to drive timely resolution of Supplier Quality related issues.
  • Identifies opportunities to continuously improve quality, compliance, cost and time factors, consistent with Integra business objectives; identifies significant business issues, prioritizes for action, and leads improvement opportunities and problem solutions.
  • Plans, coordinates, and directs quality and compliance programs designed to ensure effective and consistent supplier processes with established standards.
  • The position plays a key role in oversight, development, and approval of process validations at supplier sites.
  • The SQM is responsible for management of Supplier Related CAPA, NC, Audit Observation resolution and metrics reporting
  • Additionally, this manager is responsible for carrying out managerial responsibilities in accordance with the organization's policies and applicable laws; including interviewing, hiring, and training employees, planning, assigning, and directing work; appraising performance; addressing complaints; and, resolving problems
  • Ensure all Quality records are appropriately filed and easily retrievable in the Quality department.
  • Participate in Quality Management Reviews and monthly Quality Forums.
  • Collect and analyze performance data against defined parameters.
  • Provide leadership and guidance in the areas of CAPA, non-conformances, Product complaints, and document control. Perform other related duties as expected.

 

 


  • A minimum of a Bachelor’s Degree is required, engineering or other technical discipline highly preferred. An equivalent combination of education and experience will also be considered.
  • Minimum 10 years of professional work experience in a GMP and /or ISO regulated industry is required
  • Experience working in a Medical Device manufacturing environment is strongly preferred. 
  • Strong ability to create and approve manufacturing process validation protocols is preferred
  • Strong communication and leadership skills are essential, including experience leading teams remotely 
  • Operational Supplier Quality experience is required.
  • Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC, 21 CFR Part 820, EUMDR 
  • Strong communication, teamwork, and organizational skills
  • Strong analytical problem solving and root cause analysis skills
  • Auditing background is preferred
  • Use of ERP, PLM systems
  • Use of Microsoft office tools
  • Knowledge of statistical techniques
  • Experience or knowledge with the machining processes, injection molding, and/or electromechanical medical devides is strongly preferred

Keywords: Integra LifeSciences, Boston , Sr. Manager, Supplier Quality Engineering, Other , Mansfield, Massachusetts

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