Config Assurance Administrator
hace 3 semanas
**Transforming Quality at Medtronic**
Medtronic is seeking a highly skilled Config Assurance Administrator to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of quality in our products and processes.
**Key Responsibilities:**
- Process change orders, from simple to complex, for product, process, and system designs.
- Review and analyze change data from various functions and coordinate changes with stakeholders, including engineering, quality, manufacturing, operations, and regulatory.
- Manage the change order process and prepare for stakeholder approvals.
- Prepare change management status reports.
- Ensure customer requirements are implemented while maintaining compliance to applicable policies, procedures, regulations, and standards.
**Requirements:**
- Bachelor's degree required.
- 5+ years of experience or an advanced degree with a minimum of 3+ years relevant experience.
- Working knowledge of Microsoft Office tools and desktop publishing software experience.
- Familiarity with modern ERP systems, PLM systems, and manufacturing documentation.
- Bilingual English-Spanish communication and excellent written and verbal communication.
**Nice to Have:**
- Knowledge and experience in regulated industries, including ISO 9000, ISO 13485, and ISO 14971 requirements.
- Analytical skills and decision-making.
- Self-driven, resourceful, and results-oriented.
- Strong results orientation, including driving to deadlines, process KPIs, project goals, etc.
- Strong analytical, planning, quality, regulation, and organizational skills.
- Knowledge of Six Sigma Methodology and Lean Manufacturing.
- Proficiency in Project Management.
- Able to work independently and within a team.
- Amenable to work on a night shift schedule.
**About Medtronic:**
At Medtronic, we push the limits of what technology, therapies, and services can do to help alleviate pain, restore health, and extend life. We challenge ourselves and each other to make tomorrow better than yesterday.
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