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Quality Assurance Engineer with strong background collaborating teams, managing complex projects, and achieving strategic objectives. Skilled in the development of efficient processes, ensuring high standards, and aligning efforts with organizational goals. Experience and knowledge with document control and development per IATF standard, root cause analysis, and quality management systems. Experience communicating with customers and skills that build trusting and professional relationships. Recently certified in AIAG and CQI to demonstrate my commitment in exceeding industry benchmarks and drive continuous improvement initiatives.

Attentive Quality Engineer always ready to step in and correct production weaknesses or faults. Provides limitation of liability by applying exceptional foresight and forecasting techniques to all proposed designs and manufacturing processes. Faithful provider of streamlined and profitable development streams.

Qualified Quality Engineer accustomed to developing and monitoring improved inspection strategy to reduce errors and cultivate consistent quality. Dedicated and energetic with proven history of implementing corrective actions to drive quality and improve efficiency. Detail-oriented and motivated Quality Engineer with 4 years of extensive experience in the medical device industry, focused on product quality, regulatory compliance, and continuous improvement initiatives. Proficient in managing CAPA processes, conducting thorough root cause analysis, and ensuring compliance with FDA regulations (21 CFR Part 820) and ISO 13485 standards. Experienced in working with orthopedic implants, diagnostic devices, and women’s health products, ensuring product safety and quality across all stages of production. Adept at managing non-conformance issues and driving supplier quality improvements through SCAR initiatives. Seeking to apply a strong technical and analytical skill set to contribute to a dynamic quality assurance team in a regulated manufacturing environment.

Dynamic Engineer, skilled in ISO 9001 and corrective actions. Expert in project management, demonstrating strong communication skills and attention to detail. Successfully developed action plans that enhanced certification processes and reduced non-conforming materials, driving operational excellence.

Experienced leader with strong background in guiding teams, managing complex projects, and achieving strategic objectives. Excels in developing efficient processes, ensuring high standards, and aligning efforts with organizational goals. Known for collaborative approach and commitment to excellence.

Jessica Claire

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