Senior Quality Engineer

The Senior Quality Engineer is responsible for managing processes, resolving product issues and leading projects in a chemical manufacturing facility to maintain and improve product quality and the quality system in accordance with the requirements of, as appropriate, IS0 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR and other applicable standards. This role leads Customer complaint, Non-Conformance and CAPA investigations, supplier quality improvement actions, production and process control improvements, and product quality improvements with the use of statistical techniques and other accepted quality principles within a scientific environment. This role plans and executes activities concerned with the development, implementation, maintenance, and continuous improvement of STERIS quality systems.

• Serves as the Core Team Member on cross-functional new product development teams with focus on the execution of quality plans and design transfer specific to blended pharmaceutical detergents, disinfectants and sterile products.
• Develops, documents, and implements statistically valid sampling plans, designed experiments, capability studies, SPC, trend analysis and technical triage reports in support of product investigations and improvements.
• Leads investigation efforts, including root cause analysis, corrective actions and problem-solving activities for product and product-related manufacturing issues.
• Prepares detailed technical reports on investigation and communicate findings effectively to the stakeholders.
• Ensures compliance with regulatory standards and internal quality protocols throughout the manufacturing process.
• Works collaboratively with QA, production, R&D, Regulatory and other departments on various technical investigations.
• Reviews the current quality system to recommend / implement improvements as needed.
• Uses data to perform statistical analysis and recommend process / product changes to improve product quality.
• Leads projects focused on quality system and product quality improvements.
• Develops analyses and reports on product and process performance.
• Supports supplier audits and corrective actions as needed.
• Leads and supports internal and external quality system audits.
• Instructs other STERIS employees in quality principles, effective corrective actions, and valid statistical techniques.
• Collaborates with other departments and facilities within the company on quality related issues.
• Potentially supervise and mentor Quality Engineers and other Quality staff in the execution of their assigned duties and objectives.
• Maintains product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
• Perform all other duties as assigned.
  
  

• 8 or more years of related experience in a process chemist or process engineering role within a chemical manufacturing or pharmaceutical industry
• 3 or more years of Quality Engineering experience
• 6-10 years of experience with medical device or production of pharmaceutical detergents, disinfectants and sterilants is highly preferred.
• 6-10 years of experience working in an ISO certified environment required.
• ASQ, QSR, Six Sigma black belt or familiarity with QSR/GMP regulations preferred.

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