Staff Engineer
vor 4 Wochen
We are seeking a highly skilled Staff Engineer to join our Global Supplier Quality Development & Process Validation team. As a key member of our team, you will be responsible for ensuring the timely completion of process validation requirements for new products and life cycle change management projects with suppliers.
Key Responsibilities- Lead and communicate component/process validation requirements to suppliers
- Ensure timely completion and verification of process validations
- 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
- Provide support to sites by leading critical Supplier Quality related issues
- Review and approve executed qualification documentation with suppliers
- Develop and promote a culture of continuous improvement
- Support the supplier consolidation initiative
- Provide training on Process Validation concepts to the team and organization
- 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 experience
- Medical Device or Pharmaceutical experience is required
- Experience or knowledge of ISO 9001 and ISO 13485 requirements preferred
- Opportunity to work with a leading healthcare company
- Collaborative and dynamic work environment
- Competitive salary and benefits package
- Opportunities for professional growth and development
We are an equal opportunities employer and welcome applications from diverse candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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