Job Profile: Engineer, Quality Systems & Data

Job Profile: Engineer, Quality Systems & Data

Job Profile: Engineer, Quality Systems & Data

Info: This profile details the function of the Engineer, Quality Systems & Data, a pivotal role responsible for architecting the digital infrastructure that ensures product integrity and regulatory adherence in the cannabis technology sector.

Job Overview

The Engineer, Quality Systems & Data serves as the primary architect of data integrity and process reliability within the cannabis technology landscape. This role is positioned at the critical intersection of software development, quality assurance, and regulatory compliance. The core function is to design, validate, and continuously improve the complex software and data systems that track every aspect of the cannabis lifecycle. In an industry defined by a fragmented patchwork of state-specific regulations and mandatory seed-to-sale tracking systems like METRC, data is the ultimate asset. A single point of data corruption or system failure can trigger product recalls, costly operational shutdowns, and the potential loss of licensure. This engineer is therefore tasked with the proactive identification and mitigation of these risks, building a resilient digital ecosystem that supports operational scale while guaranteeing compliance. Through rigorous problem solving and system assessment, this individual ensures that the flow of information is as pure and traceable as the final product itself.

Strategic Insight: A flawlessly designed and validated quality data system is a significant competitive moat. It enables faster product-to-market cycles, reduces compliance risk, and unlocks powerful business intelligence for process optimization.

A Day in the Life

The day begins by analyzing the results of an automated data reconciliation script that runs overnight. This script compares production data in the company’s Enterprise Resource Planning (ERP) system with the data reported to the state’s METRC seed-to-sale traceability platform. An alert flags a discrepancy: a 5,000-unit batch of vape cartridges was packaged yesterday, but the state system only shows a 4,500-unit transfer. This initiates an immediate problem solving sequence. The engineer queries the production database to isolate the specific batch and operator logs, reviewing timestamps and system entries to pinpoint the source of the 500-unit gap. The investigation reveals a momentary network timeout during the API call to METRC, causing one data packet to fail.

With the immediate issue identified for correction, the focus shifts to prevention. The engineer initiates a collaboration session with a software developer and a compliance manager. They perform a rapid assessment of the API integration layer. The engineer proposes a more robust error-handling protocol with an automated retry mechanism and an immediate notification system for failed data transmissions. This ensures that a simple network issue does not become a critical compliance failure in the future. Following this, the engineer documents the incident and the corrective action in the Quality Management System (QMS) to maintain a complete audit trail.

Alert: Data discrepancies with state traceability systems are not administrative errors; they are potential license violations. Real-time detection and root cause analysis are essential functions of this role.

The afternoon is dedicated to a strategic, forward-looking project. The company plans to launch a new line of cannabinoid-infused beverages, which requires a new software module for tracking liquid infusion, batch homogenization, and bottling. The Engineer, Quality Systems & Data leads a Design Failure Mode and Effects Analysis (DFMEA) session. In collaboration with process engineers and software developers, they systematically map out every potential failure point in the new software design. They ask critical questions: What happens if the system allows an operator to proceed without verifying the potency of the cannabinoid distillate? What is the risk if the system miscalculates the volume-to-potency ratio, leading to an incorrectly dosed batch? For each potential failure, the team assigns a risk score and develops specific mitigation strategies, such as adding hard-coded validation checks or requiring supervisory electronic signatures for critical control points. This proactive DFMEA process designs quality and safety directly into the system before a single line of code is finalized.

The operational cycle concludes with a focus on business intelligence. The engineer finalizes a new dashboard in Tableau that aggregates and visualizes data from Certificates of Analysis (CoAs) for all raw material inputs over the past six months. The visualization reveals that a specific terpene, myrcene, shows significantly higher variance from one supplier compared to two others. This data-driven insight allows the procurement team to initiate a supplier performance assessment and work with the underperforming vendor to improve consistency. This action directly impacts the quality and sensory profile of the final product, turning quality data into a tool for strategic sourcing and product improvement.


Core Responsibilities & Operational Impact

The Engineer, Quality Systems & Data has principal ownership over three functional domains that form the digital backbone of the organization:

1. System Design & Proactive Risk Mitigation

  • Architecting Data Structures: Defining the technical specifications for how quality data is captured, stored, and linked across systems, from cultivation environmental data to final product lab results.
  • Conducting DFMEA: Leading systematic, proactive risk assessments on new software features, system integrations, and data migration plans to identify and eliminate potential failure modes before they impact production.
  • Computer System Validation (CSV): Authoring and executing validation protocols (IQ/OQ/PQ) for critical software systems to ensure they operate as intended and meet GxP and 21 CFR Part 11 requirements for data integrity and electronic signatures.

2. Data Governance & Business Intelligence

  • Ensuring Data Integrity: Developing and implementing automated scripts and validation rules to continuously monitor data quality across the ecosystem, preventing issues like incorrect unit of measure conversions or faulty lab data entries.
  • Master Data Management: Establishing and enforcing a governance framework for all critical data objects, such as strain names, product SKUs, and ingredient specifications, to ensure consistency across the enterprise.
  • Developing Business Intelligence Tools: Transforming raw operational and quality data into actionable insights by creating dashboards and reports that track key performance indicators like batch cycle times, yield analysis, and deviation trends.

3. Technical Problem Solving & Collaboration

  • Leading Root Cause Analysis: Acting as the lead technical investigator for any data-related deviations, system bugs, or compliance reporting errors, utilizing structured problem solving methodologies to identify and resolve the core issue.
  • Facilitating Cross-Functional Collaboration: Serving as the technical translator between non-technical stakeholders (Compliance, Operations) and the software development team to ensure business requirements are accurately converted into functional system designs.
  • Managing System Change Control: Overseeing the change management process for validated software systems, ensuring that any updates, patches, or configuration changes are properly tested, documented, and deployed without disrupting operations.
Warning: In the cannabis industry, an unvalidated or poorly controlled software change can be equivalent to an uncalibrated scale, creating significant product quality and compliance risks. Rigorous change control is mandatory.

Strategic Impact Analysis

The Engineer, Quality Systems & Data directly influences the organization's performance across multiple strategic vectors:

Impact Area Strategic Influence
Cash Prevents significant fines from state regulators by ensuring the accuracy and timeliness of all data submitted to seed-to-sale tracking systems.
Profits Reduces the cost of poor quality by designing systems that prevent data entry errors, thereby minimizing the risk of batch holds, rework, or destruction.
Assets Protects the company's most valuable intangible assets: its operational license and brand reputation, which are built on a foundation of data integrity.
Growth Develops a scalable and modular systems architecture that can be rapidly adapted and deployed in new states, accelerating multi-state expansion efforts.
People Empowers operational staff with reliable, easy-to-use software tools, reducing manual data entry, minimizing human error, and improving job satisfaction.
Products Leverages business intelligence to drive product consistency, using data to identify and correct process variables that impact cannabinoid potency, terpene profiles, and product safety.
Legal Exposure Creates a defensible, time-stamped, and immutable electronic audit trail for every gram of product, significantly mitigating liability in the event of a product recall or legal challenge.
Compliance Automates the collection and reporting of compliance data, ensuring that all internal processes are executed in alignment with documented and approved SOPs.
Regulatory Designs flexible and configurable systems capable of adapting quickly to changes in state-level regulations regarding testing, labeling, and reporting without requiring a complete system overhaul.
Info: Effective business intelligence in cannabis is not just about historical reporting; it's about using predictive analytics to identify potential batch failures before they occur.

Chain of Command & Key Stakeholders

Reports To: This position typically reports to the Director of Technology or the Head of Quality & Compliance, reflecting its dual focus on technical systems and regulatory adherence.

Similar Roles: This specialized role combines elements of several traditional technology and quality positions. Professionals with titles such as Validation Engineer, Systems Analyst, Data Engineer, or Business Intelligence Developer in the pharmaceutical, medical device, or food and beverage industries possess highly relevant skill sets. The role is functionally equivalent to a Computer System Validation (CSV) Lead in a GxP environment, but with the added complexity of navigating disparate state-level cannabis regulations. Within the technology sector, this position aligns with a Technical Product Manager or a Solutions Architect focused on regulated industries.

Works Closely With: This position requires deep collaboration with the Software Development Manager, Director of Operations, Lab Director, and Chief Compliance Officer.

Note: The success of this role depends on the ability to act as a bridge, translating rigid regulatory requirements into elegant technical solutions and communicating system capabilities back to operational leaders.

Technology, Tools & Systems

Proficiency with a specific technology stack is essential for operational effectiveness:

  • State Traceability System APIs: Deep technical understanding of the APIs for major seed-to-sale platforms such as METRC, BioTrack, and Leaf Logix is fundamental.
  • ERP and MES Platforms: Experience with cannabis-specific platforms (e.g., Distru, Canix) or highly customized Tier 1 systems (e.g., SAP S/4HANA, Oracle NetSuite) used for manufacturing and inventory management.
  • Business Intelligence & Data Visualization: Advanced skills in tools like Tableau, Power BI, or Looker to build dynamic dashboards and automated reports for quality and operational metrics.
  • Database and Scripting Languages: Expertise in SQL for complex data querying and analysis, along with scripting capabilities in languages like Python for data validation and automation tasks.
  • Electronic Quality Management Systems (eQMS): Familiarity with the architecture and validation of eQMS platforms (e.g., MasterControl, Veeva) for document control, training records, and CAPA management.
Strategic Insight: Mastery of traceability system APIs allows an organization to build custom workflows and analytics that go far beyond the basic web interface, creating a significant operational advantage.

The Ideal Candidate Profile

Transferable Skills

Candidates from other highly regulated, data-intensive industries are exceptionally well-positioned for success:

  • Pharmaceutical & Medical Device Manufacturing: Direct experience with Computer System Validation (CSV), GxP guidelines, 21 CFR Part 11 compliance, and Quality by Design (QbD) principles is the most sought-after background.
  • Aerospace & Defense: Expertise in systems engineering, FMEA, and managing complex Bill of Materials (BOMs) within tightly controlled manufacturing execution systems (MES) is highly applicable.
  • FinTech & Banking: A background in designing and validating software systems that require impeccable data integrity, transaction traceability, and auditable reporting for regulatory bodies translates effectively.
  • Food & Beverage (with FSMA): Experience implementing technology solutions for lot traceability, supplier verification, and compliance with the Food Safety Modernization Act (FSMA) provides a strong foundation.

Critical Competencies

The role demands a unique blend of technical acumen and strategic thinking:

  • Systemic Problem Solving: The ability to deconstruct complex data flow problems into their component parts, diagnose the root cause across multiple interconnected systems, and engineer a permanent solution.
  • Regulatory Translation: The capacity to read and interpret dense, legalistic state regulations and translate them into precise, unambiguous technical requirements and system validation protocols.
  • Proactive Risk Assessment: A mindset that defaults to identifying potential failures in advance (via DFMEA) rather than reacting to problems after they occur, ensuring system resilience and reliability.
Note: While cannabis industry experience is a plus, proven expertise in validating and managing data systems in any GxP-regulated environment is the primary qualifier for this role.

Top 3 Influential Entities for the Role

The standards and requirements governing this role are shaped by these key organizations:

  • State Cannabis Regulatory Agencies: Bodies like California's Department of Cannabis Control (DCC) or Colorado's Marijuana Enforcement Division (MED). These agencies create the specific, legally binding rules for traceability, testing, and reporting that the quality systems must be designed to enforce and automate.
  • METRC (and other S2S Providers): As the designated state contractor for traceability in many markets, METRC's API documentation, system constraints, and periodic updates directly dictate the technical architecture of any integrated software. The engineer must treat METRC as a primary design constraint.
  • International Society for Pharmaceutical Engineering (ISPE): The GAMP 5 guidelines (A Risk-Based Approach to Compliant GxP Computerized Systems) from ISPE represent the global gold standard for computer system validation. Applying these principles provides a robust, defensible framework for cannabis quality systems.
Info: Candidates who can articulate how they would apply GAMP 5 principles to a METRC integration demonstrate a superior level of strategic understanding and are highly valued.

Acronyms & Terminology

Acronym/Term Definition
API Application Programming Interface. A set of rules and protocols that allows different software applications to communicate with each other.
CSV Computer System Validation. The documented process of assuring that a computerized system does exactly what it is designed to do in a consistent and reproducible manner.
DFMEA Design Failure Mode and Effects Analysis. A systematic method to identify potential failures in a system design before the product is released.
ERP Enterprise Resource Planning. Centralized software used to manage day-to-day business activities such as accounting, procurement, project management, and manufacturing.
GAMP Good Automated Manufacturing Practice. A set of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.
GxP Good Practice. A general term for quality guidelines and regulations (e.g., GMP, GLP, GDP).
IQ/OQ/PQ Installation Qualification / Operational Qualification / Performance Qualification. The sequential phases of computer system validation.
LIMS Laboratory Information Management System. Software used in analytical labs to manage samples, tests, results, and reporting.
METRC Marijuana Enforcement Tracking Reporting Compliance. A widely used state-mandated seed-to-sale software tracking system.
QMS Quality Management System. The formal system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.
S2S Seed-to-Sale. The business process and regulatory requirement of tracking the entire lifecycle of a cannabis product.
SQL Structured Query Language. A standard language for managing and manipulating data in relational databases.

Disclaimer

This article and the content within this knowledge base are provided for informational and educational purposes only. They do not constitute business, financial, legal, or other professional advice. Regulations and business circumstances vary widely. You should consult with a qualified professional (e.g., attorney, accountant, specialized consultant) who is familiar with your specific situation and jurisdiction before making business decisions or taking action based on this content. The site, platform, and authors accept no liability for any actions taken or not taken based on the information provided herein. Videos, links, downloads or other materials shown or referenced are not endorsements of any product, process, procedure or entity. Perform your own research and due diligence at all times in regards to federal, state and local laws, safety and health services.

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