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Quality Assurance Specialist
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We are seeking a highly skilled and experienced CAPA facilitator to join our Quality & Regulatory Organization, supporting the Magnetic Resonance Imaging Business. As a key member of our team, you will play a critical role in ensuring the quality and compliance of our products.
Key Responsibilities- Support the CAPA process from issue identification to closure, ensuring proper execution and quality of CAPA record content.
- Assess complex investigations and corrective actions, reviewing test and other performance data.
- Lead root cause analysis and quality problem-solving efforts, facilitating product and process CAPA investigations.
- Assist CAPA Owners in all aspects of CAPA activities, including resource coordination, team meetings, and project timeline adherence.
- Support CAPA Owners during audits and CAPA Review Board meetings, mentoring cross-functional teams in root cause analysis techniques.
- Analyze quality monitoring data and apply statistical methods to identify causes of non-conformances.
- B.Sc in Engineering or a relevant field (e.g., statistics, quality management); advanced degrees are an advantage.
- Experience in quality roles within the medical device or other regulated industries.
- Working knowledge of global regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 9001, and ISO 14971.
- Proficiency in statistical methods, quality tools, and problem-solving methodologies (e.g., 8D, DMAIC, SPC, FMEA, Control Plan, LEAN) is an advantage.
- Experience as a team facilitator or coach.
- Experience working in complex organizations with Manufacturing, R&D, and Engineering environments.
- Strong communication and interpersonal skills with the ability to coach cross-functional teams in a matrix environment.
- Strong technical writing skills.
- Ability to resolve complex issues creatively and influence stakeholders.
- Multi-tasking and decision-making capabilities.
- Self-starter, motivated, and action-oriented.
- Experience working in a global corporate environment.
- Fluent in English.
