ORLANDO, FL – For Jennifer Maandi, language has always been about more than words. She’s fascinated by how the same idea can carry different meaning depending on how it’s expressed, a perspective that has shaped both her personal interests and her career in medical device quality.
Now, as QualityHub’s new Project Manager Administrator, Maandi brings that same attention to communication, organization, and nuance to her work supporting the consultancy’s growing portfolio of client projects.
“I believe there’s a connection between quality, regulatory, and language,” Maandi said, pointing to her BA in French Studies from Bard College. “Language is incredibly important for interpreting regulations and building regulatory arguments.”
Maandi joins QualityHub with nearly 15 years of medical device experience spanning quality systems and regulatory support across different product types, including audits under the Medical Device Single Audit Program (MDSAP) and preparation for US Food and Drug Administration (FDA) inspections. She’s also a trained biomedical auditor to ISO (the International Organization for Standardization), with additional training in implementing software for project management and enterprise resource planning (ERP).
Maandi got her start on the customer service side of Connecticut-based device company Oxford Performance Materials (OPM) before becoming drawn to how the business operated behind the scenes.
“I was really interested in writing the procedures and understanding how all the different pieces of the company interconnected through the quality system,” she said.
That curiosity pulled Maandi into the quality field where she built experience in regulatory strategy and technical writing alongside her customer-facing work, giving her a firsthand view of how companies interpret and apply regulatory requirements differently depending on the market and audience.
Her work ultimately led to a role as OPM’s Quality Systems Manager, followed by nearly five years as Quality Assurance Manager at Hobbs Medical, also based in Connecticut.
Turning Complexity Into Organization
At QualityHub, Maandi will focus primarily on the internal organization of projects, working with team members to keep deliverables, information, and workflows on track. It’s an area that closely mirrors work she’s done throughout her career.
In her pre-Quality Systems Manager role as OPM’s Customer Operations Manager, Maandi coordinated day-to-day tracking of patient-specific cases and helped build systems for communicating across departments, ensuring critical information reached the right people quickly and efficiently.
That experience translates directly to her new role, where she’ll help structure projects and deliverables and provide the backbone needed to keep work moving smoothly behind the scenes.
“I can definitely see all of my skillsets coming into importance in my new role here at QualityHub, and I’m excited to get started,” she said.
Founded in 2004 on the principles of quality and a commitment to continuous improvement, QualityHub provides support in an array of technical areas, including product and quality systems development, auditing, complaint handling, supplier control, clinical compliance, training, and much more. Discover what QualityHub’s compliance consultants, project managers, and regulation experts can do for your company today.
