Experience

CQ Medical
• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee
• Director of Quality Systems & PA Site Quality

  • Sep 2022 - Present

Qfix & Civco RT Better Together
• Director of Quality Systems & Pennsylvania Site Quality

  • Feb 2023 - Oct 2023


Qfix

• Qatar
• IT Services and IT Consulting
• 1 - 100 Employee

• Director Of Compliance

  • Mar 2022 - Apr 2023

• Kaizen Office & Product Labeling Manager

  • Jul 2019 - Mar 2022

• Manager, Technical & Engineering Documentation

  • Jun 2016 - Jul 2019



Therakos is now a part of Mallinckrodt Pharmaceuticals.

• Manager, Packaging & Labeling

  • Jan 2014 - May 2016

  • Nearly 10 years of experience in an FDA regulated environment. Ensured compliance for FDA, BSI, and CE marking requirements. • Carved Product Labeling out of Johnson & Johnson and built the group from the ground up establishing Quality Processes and Procedures. • Manage a motivated, empowered Labeling Group with current software tools and streamlined processes. • Manage creation and maintenance of customer facing documentation including Operator’s Manuals, instrument and consumable labeling, and (M)SDS. • Lead the UDI Team to implement labeling requirements for Class III medical devices. • Launched a Labeling document library to support sales and clinical service. • Core Team Labeling Representative for all Product Development Projects. • High level management skills with cross-functional teams: Regulatory, Engineering, Marketing, Quality, Supply Chain, Operations and Manufacturing. • Thorough understanding of the device and how it operates. Regularly complete verification and validation of user instructions on the device running non-patient therapies. • Manage CAPA activities for Labeling and User Documentation. • Create project charters for Labeling projects from conception through launch and post-launch activities for global projects. • Thorough knowledge of design controls, change management and product development processes. • Manage resources, suppliers, and translation budgets. • Write and maintain functional Quality Procedures. Show less



Siemens Healthcare

• Italy
• Medical Device
• 1 - 100 Employee

• Product Labeling

  • Jul 2007 - Dec 2013

  Subject Matter Expert for all packaging and labeling artwork for 2 product lines. • Responsible for maintaining and supporting approximately 5000 artwork files. • Supported 22 languages. Manage translation and validation with external translation vendor and internal In-Country Reviewers. Manage translation costs within budget. • Core Team Labeling Representative for all new Product Development from first milestone through FDA clearance to worldwide product launch. • Labeling Lead for cross-functional teams. Regular interaction with Manufacturing, Engineering, Supply Chain, Regulatory Affairs, Global Product Support, Global Marketing, Research and Development, and other functional groups. • Project lead on cross-functional projects. • Represented Product Labeling on global projects such as electronic IFU initiatives, industry required barcoding, GHS (hazards), global compliance initiatives, and FDA and ISO Standards and regulations. Oversee labeling changes when standards change. • Responsible for creating and maintaining industry required symbols and symbols keys • Close working relationship with manufacturing to build new labeling processes and implement changes. • Wrote validation protocols and project plans including resource and financial costs. • Maintained a strong, embedded Quality focus within an ISO driven Quality System. Create and update Quality Procedures and Quality Forms. Familiar with the CAPA (Corrective and Preventative Action) process. • Documentum® experience • Strong Adobe Creative Suite 6 (Illustrator, InDesign) skills on both Macintosh and PC. Show less


EPMonthly
• United Kingdom
• Designer

  • Jan 1998 - Sep 2007