Client: Integra Lifesciences / October 2022- Present- Create EU MDR technical documentation for a specific product family.- Review and approve document updates to ensure EU MDR compliance.- Work with other departments to ensure all necessary documentation exists to show EU MDR compliance.

- Ensured compliance to ISO 13485 and other applicable regulations.- Led EU MDR transition project including quality system updates and creation of technical documentation.- Created and compiled document submissions for international agencies and distributors and maintained international registrations.- Participated as a core team member for product development projects.- Created and reviewed 510(k) submissions.- Participated in third-party audits and internal audits- Performed adverse incident reporting (MDRs, EC Vigilance)- CAPA Coordinator

- CAPA Coordinator- Internal Audit Coordinator- Participated in third-party audits- Assisted with processing of complaints- Supervised Incoming QC inspections- Created Certificates of Compliance and Analysis for customers and regulatory agencies- Coordinated environmental monitoring activities

• Assist in reviewing pending regulatory submissions• Assist in conducting Post Market Reviews• Perform Internal Audits • Administers changes to documents in accordance with company requirements• Tracks all routing and approval stages• Ensures new documents and records are consistent with company procedures• Reviews documentation for accuracy, completeness and consistency in content, format, files and approvals• Manages external standards, controlling quality records, compiling data and generating requested reports• Maintains Quality Records• Maintains Training System• Maintains Calibration System

• Edit website and Facebook page for First Congregational Church in Saugus, MA as needed.• Post bulletins, newsletters, calendars, photos, and other items.• Manage side Facebook pages for Saugus Faith Community (previously Saugus Clergy Association) and Every Child Deserves to Smile (missions project to support homeless children in Saugus).• Created Twitter account for First Congregational Church to share news and events.

• Participated in monthly upkeep of Integrated Master Schedule (IMS) for Main Reduction Gear (MRG) project and provided customer with 4-week look ahead of upcoming tasks.• Created Critical Quality Indicators (CQI) presentations for Navy Projects• Performed CAR creation in TSM database• Performed Quality data entry and chart creation for Navy Projects • Managed incoming contracts and performed payroll and accounting activities

• Create and track the life cycles of all non-conformance and corrective action reports. • Assist in facilitating Non-conformance Board (NCB), Corrective Action Record (CAR), and Trend meetings by creating and distributing meeting agendas and minutes. • Ensure timely and accurate data for inspections and NC/CAR trending by generating and maintaining required metrics. • Support external and internal quality system audits by gathering all required information.

• Calibrated numerous pieces of equipment; liaised with calibration companies to track incoming and outgoing equipment. • Tracked metrics of top defects and inspection metrics for review by management • Recorded non-conformities in the Pilgrim database and managed associated paperwork.

• Conducted final quality control tests, prior to market release, for the Intra-Aortic Balloon Pumps; inspected in-process parts and assemblies for defects or specification errors. • Tracked all paperwork and entered non-conformities using Pilgrim software.

• Created a “safe” parts database, using excel, designed to document components material properties for flammability ratings and metal strength; utilized by the head of the Mechanical Engineering Department. • Created numerous engineering models and parts drawings for ion implanters using Pro Engineer. • Logged Engineering Change Requests (ECR’s) and Engineering Change Orders (ECO’s).

Employed for 2 seperate 3 month co-op terms 3/02-6/02 and 1/03-3/03• Created and revised engineering drawings, schematics, instructions, and parts lists. • Completed cassette assembly using ultrasonic welder; tested cassettes for air leaks. • Designed a device, using Pro Engineer software, to replace existing needles in a safety wing needle apparatus with a specialized needle designed to reduce skin displacement.