Heather Pequignot, Cqe, Cqa Email & Phone Number

Alpharetta, Georgia, United States

The Director of Quality Systems, in conjunction with the Vice President of Quality and the Quality Systems teams, is responsible for developing, implementing, and supporting the company’s quality strategies for assigned projects on various cross-functional teams. This role supports and executes initiatives that advance the company’s goals for compliance with applicable laws, and regulations. The Director of Quality Systems provides advice and guidance for and actively contributes to the development, implementation, and maintenance of the quality management system activities ensuring compliance with regulatory requirements and industry standards for both divisions of the company (Medical and Performance Materials).

Alpharetta, Georgia

Contribute to the company's products, profitability and markets by managing medical device quality systems and regulatory activities. Supervises document control and quality records, manages internal auditing and change control, plans and schedules management review, communicates with Notified Bodies and ensures the company's U.S. and international regulatory compliance (GMP/ISO 13485).

Led medical device Shelf-Life Engineering to facilitate stability determination. Determined and coordinated vendors for storage, and internal and external testing facilities. Facilitated timelines, goals, and budgets with program management. Coordinated manufacture of all needed samples and lots with internal and external operational groups. Maintained study binders and wrote protocols and reports on all studies performed.

Supported existing products and developed Protein Hydrogel Technology (PHT) platform into new products. Conducted laboratory and literature research to evaluate diverse aspects of PHT (BioGlue®, BioFoam, etc.). Facilitated formulation, product manufacture, raw material procurement, testing, analysis, and reporting.

Research Tech on BioAdhesives group to Senior Research AssociateSupported existing products and developed Protein Hydrogel Technology (PHT) platform into new products. Conducted laboratory and literature research to evaluate diverse aspects of PHT (BioGlue®, BioFoam, etc.). Facilitated formulation, product manufacture, raw material procurement, testing, analysis, and reporting.