Senior Quality Engineer, Design
4 weeks ago
We are seeking a highly skilled Senior Quality Engineer, Design to join our team at Integra LifeSciences. This role will be responsible for leading and supporting the design and development of new and improved products in close collaboration with Product Development, Project Management, Regulatory, Marketing and Medical Affairs.
Key Responsibilities- Lead and support the design and development of new or improved products
- Support Design Reviews, Technical Reviews, and Gate Reviews
- Lead and support the execution of all Risk Management and Usability Engineering process activities
- Author or review for approval other Risk Management Documentation
- Support external partners in the development of products
- Coordinate, review and approve development documentation created by external partners
- Develop Reliability models for predicting product performance over time
- Lead implementation of SPC programs with Manufacturing and Quality Control
- Maintains knowledge of and applies statistical analysis to support data-driven decision making
- Work with project teams to develop DOEs and statistically sound tests
- Develop statistically based sampling plans for Design Verification and Validation
- Participate in FDA inspections, ISO Certification and surveillance audits, customer audits and internal audits
- Writing & coordinating efforts for the development and implementation of new and updated Quality System procedures
- Ensure that all projects are in compliance with GMP, QSR, ISO or other applicable requirements
- Identify and implement opportunities for continuous improvement in the quality system
- Interact and coordinate activities with other departments, external vendors, and customers
- Bachelor degree in Science, Engineering (Biomedical, Mechanical or Electrical) or related discipline
- Minimum of 4 years of experience in Quality Assurance role for medical device or pharmaceutical manufacturing
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
- Demonstrates excellent organizational, verbal and written communication skills
- Proficient with the MS Office Suite, and statistical software
- Must be able to work independently with minimal supervision
- Able to prioritize projects and manage time to meet organizational goals and objectives
- Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA)
- Knowledge of TrackWise preferred
- Knowledge of Agile product lifecycle management system preferred
- Demonstrated knowledge and understanding of applicable national and international regulations and standards
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