The Quality Improvement Engineer is responsible for documenting, reviewing, and facilitating root cause analysis investigations associated with the production of cosmetic and OTC drug products. This position assists in improving and implementing the organization’s Quality Systems under the direction of Quality Management, collaborates closely with Operations, R&I, Quality, and Commercialization in the execution of Notices of Event (NOEs) and Corrective and Preventive Actions (CAPAs) within specified timelines. The Engineer also provides support and assists in developing innovative technical solutions to complex problems and proactively initiates innovative procedures to optimize processes.
Responsibilities and Essential Duties
- Provide support for product quality and manufacturing activities, ensuring effective and sustainable business processes.
- Manage NOE and CAPA systems to ensure timely and compliant closure and response to both internal and external customers.
- Lead investigations into undesirable trends and unplanned events, conducting root cause analysis and implementing effective CAPAs.
- Enhance existing Quality Systems and contribute to the development of quality processes by implementing associated procedures and documentation.
- Conduct and oversee regular audits and inspections of production processes and products.
- Offer technical support for initiatives to improve product and process capability based on company and customer metrics.
- Compile, maintain, and report Quality metrics as necessary.
- Support internal and external compliance audits, providing defense of work to customers and regulatory agencies.
- Assist in creating and reviewing Quality Agreements with input from Quality Management and Contracts.
- Continuously seek to improve processes and service quality for both internal and external customers.
- Maintain a professional demeanor and appearance, representing the Company effectively.
- Other duties as assigned.