The chosen candidate will provide quality leadership and direction in quality assurance, control, and preventative activities within operations and other business functions, focusing on preventative measures and continuous improvement of products and processes.
Advocate and lead the execution of initiatives & projects to enhance quality performance within the business.
Mentor and provide technical direction across multiple areas of expertise.
Ensure compliance with regulations and standards.
What you will do:Will work within the quality operations team, under minimal supervision, with responsibility for quality-related activities, including, but not limited to the following:
Work closely with operations and the business functions to ensure quality performance of products and processes.Mentor, provide oversight, and approve NC & CAPA, acting as a high-level expert in problem-solving and root cause analysis.Initiate and lead the development and improvement of manufacturing processes for existing and new products.Oversee and lead investigations during concession management.Review and approve change management activities, challenge change effectiveness, and drive strong reviews.Interpret KPI trends, take action as necessary, driving a continuous improvement process.Advocate for Human Factor practices, proficient in the science of Human Factor identification and mitigation.Serve as a subject matter expert in risk management practices and tools, having high expertise in process risk.
Develop and provide input for risk management by identifying opportunities and weaknesses.Provide technical direction in the optimization of inspection methods and sampling.Demonstrate high proficiency in statistical methods and their application.Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of the topic of expertise and overview of the business.
Manage audit logistics and preparation.Aid in the development of validation strategies, certified in one or more areas of validation including approval of validation.Support manufacturing transfers to other plants/facilities, leading quality activities.Qualification Knowledge SkillsBachelor's degree in Science, Engineering, or equivalent/related subject and 4 years of work experience in a quality discipline.
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