Technology Program Quality Assurance Engineer

Covetrus

19h

About The Position

The Technology Program Quality Engineer is responsible for executing and enhancing Quality Engineering activities for In-Clinic & Pharmacy Quality and Regulatory processes, with a strong emphasis on technology, systems integration, and data-driven decision-making. This role leverages advanced digital tools, current technologies, automation, and quality platforms to drive efficiency, scalability, and consistency across the quality management system. Working closely with Quality and Regulatory Operations leadership, the Technology Program Quality Engineer ensures that procedural and operational practices are compliant with regulatory requirements while optimizing systems and workflows through technical expertise. This role plays a key part in strengthening quality infrastructure by supporting system improvements, leveraging technology to drive efficiencies, advanced analytics, and continuous process innovation to meet evolving business and regulatory needs.

Requirements

Demonstrated ability to use modern productivity and AI tools (e.g., Copilot, ChatGPT, Claude) to analyze data, streamline workflows, and accelerate problem-solving.
Strong technical writing skills with the ability to interpret complex data and translate insights into actionable improvements.
Experience with or strong interest in low-code/no-code automation tools (e.g., Power Automate or similar).
Strong curiosity and continuous improvement mindset, with a willingness to experiment with new technologies and approaches to enhance quality systems and processes.
Ability to identify automation opportunities and translate them into actionable solutions, collaborating with technical teams where needed.
Strong collaboration skills, with the ability 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.
Experience with leveraging technology to drive process standardization and efficiency.
Working knowledge of Drug Supply Chain Security Act (DSCSA) and system-related compliance requirements.
Knowledge of data integrity principles and electronic system compliance.
Strong technical writing skills with the ability to produce clear, accurate, and compliant documentation.
Demonstrated ethical conduct; serves as a role model for quality and compliance.
Strong communication skills with the ability to collaborate effectively across technical and non-technical teams.
Strong organization skills, attention to detail, and ability to manage multiple priorities in a fast-paced environment.
Proven problem-solving skills with a focus on root cause analysis and sustainable solutions.
Proficiency in Microsoft Office applications (365/power automate/copilot); experience with data visualization tools (e.g., PowerBI, Tableau) preferred.
Ability to take direction, provide technical input, and appropriately escalate issues to ensure high-quality outcomes.
Bachelor’s degree in a related field: Engineering, Computer Science, Information Systems, Chemistry, Biology, Pharmacy, Supply Chain or similar technical discipline.
Minimum 3-5 years of experience in quality engineering, quality systems, or a related technical quality role within pharmaceuticals, healthcare, or regulated environments; or equivalent combination of education and experience.

Nice To Haves

Certified Quality Engineer (CQE) or related certification (preferred)
Lean Six Sigma (Green Belt or higher) or other Continuous Improvement certification (preferred)
Certification or experience in quality systems validation or CSV (Computer System Validation) a plus

Responsibilities

Identify and prioritize opportunities to automate manual, repetitive, or error-prone processes across quality and regulatory workflows.
Leverage modern tools (e.g., AI assistants such as Copilot, ChatGPT, Claude; low-code platforms such as Power Automate) to design and implement practical automation solutions that improve efficiency, accuracy, and scalability.
Administer and optimize Quality Management Systems (QMS), electronic documentation systems, and integrated quality platforms to ensure data integrity, systems reliability, and regulatory compliance.
Develop, maintain, and enhance dashboards, automated workflows, and data analytics tools to monitor quality metrics, identify trends, and enable proactive decision-making.
Collaborate with IT and cross-functional teams to implement system integrations, automation solutions, and digital enhancements that improve QMS processes, quality operations and scalability.
Support and enhance day-to-day applicable QRO processes by applying engineering principles and technical solutions to ensure compliance with regulatory requirements and internal standards.
Work to identify opportunities and develop solutions to improve complex investigations related to complaints, Nonconformance Events (NCE), and CAPA, incorporating data analysis, root cause analysis tools, and system-based insights.
Drive improvements in quality processes related to: Recall management systems and traceability, Supplier quality systems and performance monitoring, Drug Supply Chain Security Act (DSCSA) compliance systems and data exchange, In-Clinic new item approval workflows and system enablement.
Ensure quality systems and electronic records comply with SOPs, regulatory requirements, and data integrity standards (e.g., ALCOA+ principles).
Design and maintain standardized documentation frameworks within QMS and related systems to ensure 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.
Support internal audits, regulatory inspections, and system validations by providing technical expertise and ensuring system readiness compliance.
Identify opportunities for process 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 in accordance with established timelines.
Perform all other duties assigned to support quality and business objectives.