Quality Assurance Lead
hace 2 días
About the Role:
We are seeking a Quality Assurance Lead with experience in process engineering to join our team. This is a critical role that requires strong leadership skills, technical expertise, and excellent communication abilities.
Key Responsibilities:
- Lead the quality engineering team to achieve global quality objectives
- Identify manufacturing process defects through dispositioning non-conforming material, primary root cause analysis, and corrective/preventative actions
- Collaborate with process owners to develop product stop bounds and document release criteria
- Develop an understanding of product quality plans, documents, and systems by reviewing product specifications, quality specifications, and working with quality systems
- Learn risk analyses and FMEAs
- Monitor systems by becoming familiar with system applications, critical process steps, and methods used to reduce process variation
- Become familiar with product/process improvement efforts through quality metric data analysis and various analysis methods used to enhance sustaining product design and new product development
- Develop quality tools and training materials by gaining knowledge of prevalent tools and reviewing/utilizing available training materials
- Lead, check, and provide support in the execution and investigation of CAPAs, NCEPs, Failure Mode Investigations, etc.
- Review and develop process validation protocols and reports
- Support other functional areas during validation activities: run, review, or approve protocols/reports IQ's, OQ's, and PQ's as well as any other document relating to validation
- Read, understand, and interpret technical drawings, procedures, and protocols
- Assure laboratory equipment compliance for analysis activities (calibration, safety, cleanliness)
- Document investigation findings in analysis report on GCS2
- Become a trainer for software related to complaints handling process (GCS2), as required
Required Skills and Qualifications:
- Bachelor or Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or related field
- English language proficiency level 80-89%
- At least 5 years of technical experience
- Desirable ASQ Certified, ASQ certification (CQE, SSGB) desired, problem-solving, formal training on statistical and quality techniques desirable, knowledge of QSRs, networking, ASQ Certified
About Boston Scientific:
We are a leader in medical science committed to solving healthcare challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and communities. We're a global business and global corporate citizen with a responsibility to apply our values to everything we do. Choosing a career with us isn't just business; it's personal. If you're a natural problem-solver with imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you.
Benefits:
- Life-work integration
- Community
- Career growth
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