Elizabeth Bereza, Msra, Rac-Devices, Rcc-Mdr, Cmda Email & Phone Number

Chapel Hill, NC, US

Blue Bell, Pennsylvania, US

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.

Beverly, MA, US

- 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.

Beverly, MA, US

- 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

• 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

Wayne, PA, US

• 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.

US

• 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.

US

• 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).

US

• 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.

Masters Of Science, Regulatory Affairs For Drugs, Biologics, And Medical Devices

Masters, Leadership / Project Management

Bachelors, Mechanical Engineeering Technology