Senior Quality Manager

il y a 1 jour

Luxembourg Amazon EU SARL Temps plein

Master’s degree in quality or a similar related discipline with a scientific focus
- 5+ years of equivalent experience in quality, risk management, program management within the medical device, pharmaceutical or another regulated industry
- Knowledge of legislations, and the interplay with regulators and/or market surveillance authorities
- Essential know-how in supply chain of medical devices, pharmaceutical or another regulated industry
- Knowledge and experience in working with GxP and vigilance processes.
- Ability to work well in a matrix structure and a dynamic corporate culture
- Excellent written and verbal communication skills, with strong attention to detail
- English and at least one other EU language.

Job summary
At Amazon, we are working to be the most customer-centric company on earth and to grow in a safe environment for both our associates and our customers. To get there, we need exceptionally talented, bright, dynamic and driven people. If you would like to help us build the place to find and buy anything online, this is your chance to make history.

Key job responsibilities
- Develop, implement, and manage Quality Management System processes incorporating new and updated standards, regulations, and guidelines to ensure compliance
- Work across teams such as operations, compliance, legal, business, transportation, and Tech to provide quality oversight and mentoring
- Provide leadership, coaching and QMS training to maximize team strengths and deliver against performance objectives
- Demonstrate excellent judgement and instincts in decision making to ensure compliance for quality management system and documentation.
- Conduct and manage internal audits, and assist in third party audits and inspections
- Initiate, implement, direct quality issue resolution for complaints, nonconformances, etc. and conduct root cause and CAPA investigations as required
- Improve oversight and audits of subcontractors and suppliers to determine compliance with appropriate standards and regulations
- Establish and implement metrics to support a culture of compliant continuous improvement and predict trends
- Experience building a quality management system from the ground up
- Proven ability to independently and simultaneously manage complex, multiple, competing priorities
- Proven ability to manage ambiguity, and influence strategic roadmap through stakeholder and leadership alignment
- Analytical and quantitative skills and data-driven decision making
- Expertise in problem solving ambiguous issues through logical thinking, root cause analysis and development of robust solutions
- Ownership attitude and willingness to dive deep into details and get things done
- Demonstrate experience proactively recognizing a challenge or problem and working with a variety of teams and data sources to diagnose the problem and recommend solutions
- Continuous improvement background (i.e. 6-sigma, ISO, CAPA etc.)
- Experience in delivering and maintaining quality programs like Quality Management System in large scale operations, supply chain or manufacturing

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