Quality Assurance Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Identify and prioritize opportunities to automate manual, repetitive, or error-prone processes within quality and regulatory workflows.

• Utilize modern tools (e.g., AI assistants like Copilot, ChatGPT, Claude; low-code platforms such as Power Automate) to design and implement effective automation solutions that enhance efficiency, accuracy, and scalability.

• Manage and optimize Quality Management Systems (QMS), electronic documentation systems, and integrated quality platforms to ensure data integrity, system reliability, and adherence to regulatory standards.

• Create, maintain, and improve dashboards, automated workflows, and data analytics tools to track quality metrics, recognize trends, and facilitate proactive decision-making.

• Collaborate with IT and cross-functional teams to implement system integrations, automation solutions, and digital enhancements that refine QMS processes, quality operations, and scalability.

• Support and enhance daily applicable QRO processes by applying engineering principles and technical solutions to ensure compliance with regulatory standards and internal policies.

• Identify opportunities and develop solutions to enhance complex investigations related to complaints, Nonconformance Events (NCE), and CAPA, utilizing data analysis, root cause analysis tools, and system-based insights.

• Lead improvements in quality processes concerning Recall management systems and traceability, Supplier quality systems and performance monitoring, Drug Supply Chain Security Act (DSCSA) compliance systems and data exchange, and In-Clinic new item approval workflows and system enablement.

• Ensure quality systems and electronic records adhere to SOPs, regulatory requirements, and data integrity standards (e.g., ALCOA+ principles).

• Design and maintain standardized documentation frameworks within QMS and related systems to guarantee accuracy, traceability, and audit readiness.

• Identify systemic risks, data inconsistencies, and process gaps; implement technical controls and automated solutions to mitigate quality and compliance risks.

• Assist with internal audits, regulatory inspections, and system validations by offering technical expertise and ensuring system readiness compliance.

• Seek opportunities for the implementation of continuous improvement initiatives.

• Collaborate with QRO leadership, IT, Supply Chain, and other cross-functional teams to design and implement scalable quality solutions.

• Provide technical guidance and training to team members on quality systems, automated processes, tools, and data utilization.

• Complete all required training within established timelines.

• Perform all other duties as assigned to support quality and business objectives.

⛳️ Requirements

• Bachelor’s degree in a relevant field: Engineering, Computer Science, Information Systems, Chemistry, Biology, Pharmacy, Supply Chain, or a similar technical discipline.

• A minimum of 3-5 years of experience in quality engineering, quality systems, or a related technical quality role within pharmaceuticals, healthcare, or regulated environments; or an equivalent combination of education and experience.

• Proven ability to utilize modern productivity and AI tools (e.g., Copilot, ChatGPT, Claude) for data analysis, workflow streamlining, and accelerated problem-solving.

• Strong technical writing skills with the capability to interpret complex data and convert insights into actionable enhancements.

• Experience with or a strong interest in low-code/no-code automation tools (e.g., Power Automate or similar).

• A strong sense of curiosity and a continuous improvement mindset, with a willingness to experiment with new technologies and methods to enhance quality systems and processes.

• Ability to identify automation opportunities and translate them into actionable solutions, collaborating with technical teams as needed.

• Excellent collaboration skills, with the capacity to work effectively across Quality, IT, Product, and Operations to implement scalable solutions.

• Experience with Quality Management Systems (QMS), data analytics tools, and process automation platforms.

• Knowledge of leveraging technology to drive process standardization and efficiency.

• Familiarity with the Drug Supply Chain Security Act (DSCSA) and system-related compliance requirements.

• Understanding of data integrity principles and electronic system compliance.

🏝️ Benefits

• 401k savings & company match

• Paid time off

• Paid holidays

• Maternity leave

• Parental leave

• Military leave

• Other leaves of absence

• Health, dental, and vision benefits

• Health savings accounts

• Flexible spending accounts

• Life & disability benefits

• Identity theft protection

• Pet insurance