Sr. Quality Engineer / Quality Operations (Validations, Risk Management & Statistics)

Integra Lifesciences Holdings Corporation-posted 9 months ago
Mid Level
Management of Companies and Enterprises
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The Sr. Quality Engineer / Quality Operations (Validations, Risk Management & Statistics) will provide Plant Quality compliance support for the following Quality tasks and duties: Assist in the Introduction and launching of new or improved products and processes into the Manufacturing Site. Participate in problem solving teams. Facilitate from a Quality Engineering & Quality Systems and Plant perspective the launching of new or improved products/processes. Provide guidance on the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects. Facilitates the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products is in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

  • Assists in the launching of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
  • Providing guidance on the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
  • Participate in the execution of Process FMEA and other applicable risk analysis documentation as deemed appropriate.
  • Develop statistically based sampling plans for in-process and finished goods testing, inspections, validations and where required.
  • Provide Statistical Analysis of the data to support all Quality Systems documentation such as validations, NCs, Complaints, etc.
  • Develop, review and approve validations and completion reports for new and existing products, processes and equipment.
  • Prepare monthly and quarterly trending, including Statistical Process Control documentation, and support the Quality Management Review Process.
  • Maintains a thorough understanding of the following regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485:2003, Medical Device Directive (MOD), the Canadian Medical Device Regulations (CMDR), Integra Corporation's policies and procedures, and other applicable regulatory agency requirements.
  • Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
  • Perform other Quality Assurance and Quality Engineering related duties as required.
  • Education: Bachelor's Degree in engineering preferred (Biomedical, mechanical, chemical, or electrical) or Science (Biology).
  • Certifications: ASQ CQE preferred.
  • Experience: 6 to 8 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
  • Demonstrates knowledge of statistical sampling and analysis.
  • Demonstrates excellent organizational, communication, and project management skills.
  • Proficient with the MS Office Suite, and statistical software.
  • Must be able to work independently with minimal supervision.
  • Able to prioritize projects to meet organizational goals and objectives.
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