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Job description
Staff Engineer, Quality
What we are looking for:
The chosen candidate will provide quality leadership and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus 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 to regulation 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 product and processes.
- Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.
- Initiates and lead in the development and improvement of the manufacturing processes for existing and new products.
- Oversight and leads investigations during concession management.
- Review and approval of change management activities, challenges change effectiveness and drives strong review.
- Interpret KPI trends, take action as necessary, driving a continuous improvement process.
- Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
- 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.
- Proficiency in and provides technical direction in optimization of inspection methods and sampling.
- High proficiency in statistical methods and application.
- Participate in and may lead internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. Manages audit logistics and preparation.
- Aids in the development of validation strategies, certified in 1 or more areas of validation including approval of validation.
- Support manufacturing transfers to other plants/facilities, leading quality activities.
Qualification Knowledge Skills
- Bachelor degree in Science, Engineering or equivalent/ related subject and 4 years of work experience in a quality discipline