Staff Engineer
vor 2 Monaten
At Integra LifeSciences, we're committed to creating a culture of continuous improvement that drives change and shapes the future of healthcare. As a Staff Engineer - Global Supplier Quality Development & Process Validation, you'll play a critical role in ensuring the timely completion of process validation requirements for new products and life cycle change management projects with suppliers.
Key Responsibilities:- Ensure supplier process validation requirements are communicated, completed, and verified for each responsible group.
- Drive continuous improvement in supplier quality processes through data analysis and identification of areas for improvement.
- Perform for-cause audits to determine root cause and drive CAPAs while supporting the site supplier quality teams.
- Review and approve executed qualification documentation (IQ/OQ/PQ) with suppliers for new product and LCM projects.
- Develop and promote the right behaviors to sustain a culture of continuous improvement necessary to support both short- and long-term business objectives.
- Bachelor's degree or equivalent with 10+ years of experience, master's degree with 8+ years of experience, Doctoral degree with 5+ years of experience in manufacturing engineering, Mechanical Engineering, Industrial Engineering or Sciences.
- Minimum 8 years of experience in quality or manufacturing with bachelor's degree.
- Strong experience in process validation and component qualification - IQ/OQ/PQ and data analytics.
- Medical Device or Pharmaceutical experience is required.
- Experience or knowledge of ISO 9001 and ISO 13485 requirements preferred.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Collaborative and dynamic work environment.
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