Quality Improvement Engineer

Position Summary

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.
  
  

Technical Skills Required

• Strong technical acumen.
• Up-to-date knowledge of FDA regulations and Good Manufacturing Practice (GMP) regulations.
• Excellent communication skills, both oral and written.
• Proficiency in project management to coordinate multiple projects and meet tight deadlines.
• Track record of managing audits and maintaining compliance with regulatory authorities.
• Proficiency in Microsoft Office and quality management software; experience with SharePoint, M-Files, LIMS systems, and SAP is highly beneficial.
• Ability to work independently and collaboratively, managing multiple priorities in a dynamic environment.
• Strong analytical and problem-solving skills with sound decision-making abilities.
• Detail-oriented with proven ability to prioritize tasks.
• Ability to provide leadership for a small team of Quality Investigators.
  
  

Education And Experience Required

• Bachelor’s degree in engineering or another STEAM field (Science, Technology, Engineering, Arts, Mathematics), or 3 years minimum experience in Quality Engineering or Engineering within the food, medical device, pharmaceutical, or cosmetic fields.
• Understanding of quality system regulations, cGMP, and ISO standards.
• Preferred experience in root cause analysis and CAPA development/implementation.
• ASQ certification for CQM/OE, CQA, or CQE is desirable.
  
  

Physical Requirements

• Must be able to climb stairs, stand for long periods of time and can bend.
• Move, transport, and position up to 25 pounds.
• Move about inside the production environment safely.
• Drive to offsite locations for investigations or audits either internal or external.
• While performing the duties of the job, the employee is frequently exposed to fumes or airborne particles, moving mechanical parts, and vibration if working in the production areas of the building.