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Stephanie Ojeda

Vice President of Product Management

AssurX

Stephanie Ojeda is vice president of product management for life sciences and manufacturing at AssurX. She brings more than 18 years of hands-on experience leading quality assurance functions in pharmaceutical, biotechnology, medical device, food and beverage, and manufacturing sectors. Her deep expertise on the consumer side of quality management system software enables her to infuse AssurX’s product strategy with real-world insights and practical perspectives, enhancing value for customers worldwide.

Thu, 12/08/2022 - 12:02
The Supplier Life Cycle Tool Kit Matching the right quality tool to every stage
Mon, 09/28/2026 - 12:02
A quality team’s supplier toolbox is deep. Supplier questionnaires, PPAP, supplier scorecards, incoming inspection, audits, corrective action—the list goes on. In my years of experience as a quality leader, the challenge I see is matching each one…
Protecting Food Quality in the Wake of the Cyclosporiasis Outbreak A robust QMS is essential
Tue, 08/18/2026 - 12:02
The recent multistate outbreak of cyclosporiasis is a powerful reminder that food quality involves more than appearance, consistency, and shelf life. It requires an integrated approach to food safety, supplier control, traceability, risk management…
Why Risk-Based Supplier Audits Are Replacing Calendar-Based Audits Save time and spend it on suppliers that need attention
Tue, 06/30/2026 - 12:02
In the larger organizations I worked for as a quality leader, supplier auditing was almost always calendar-driven. Sometimes supplier audits happened once a year; in other places, they might happen twice. I’d build the schedule to accommodate that,…
How EQMS Helps FDA-Regulated Teams Grow Scaling without breaking
Tue, 05/12/2026 - 12:03
Growth has a way of outpacing the quality systems built to support it: more products, more sites, more users, more regulatory requirements, and the quality team is expected to absorb all of it. Document reviews stall waiting for approvals. Training…
Why Manufacturers Must Transform EHS Management Now Time to move from reactive to resilient
Mon, 04/06/2026 - 12:03
In the high-stakes world of modern manufacturing, environmental, health, and safety (EHS) management is no longer a back-office checkbox. It has become a strategic function that directly affects worker safety, regulatory compliance, operational…
The Importance of Integrating EHS and Quality Management Systems Centralize tracking of quality and safety, streamline compliance with ISO standards, reduce risk, and improve visibility
Wed, 02/25/2026 - 12:01
Integrating environmental, health, and safety (EHS) with quality management is no longer optional for manufacturers; it’s essential for achieving operational excellence, ensuring ISO compliance, and driving sustainable growth. Traditionally, EHS…
The Hidden Cost of a Fragmented QMS in Life Sciences It’s a financial and operational drain on life science companies
Tue, 11/25/2025 - 12:03
Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational…
Building a Strong EQMS Foundation Why document control and training come first
Mon, 11/10/2025 - 12:02
When organizations implement an enterprise quality management system (EQMS), the instinct is often to begin with high-visibility processes like corrective and preventive action (CAPA) or supplier quality. While these functions are critical, starting…
5 Essential Elements Shared by Leading Supplier Quality Management Systems Manage risk effectively with quality controls in place
Thu, 08/21/2025 - 12:03
Global-scale events have tested the bounds of supply chain systems. The coronavirus, for example, made it clear how critical an efficient supply chain is for continuity and survival. It’s a real-world example of how important it is to have an…
Supplier Scorecards vs. Spreadsheets Risks of manual tracking
Wed, 07/16/2025 - 12:01
Spreadsheets are usually the first tool used to manage suppliers, and the first to become a liability. Important updates get buried. Repeat supplier problems start popping up. Along the way, you start to wonder whether that cheaper vendor is really…

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