Janine Nunes Email & Phone Number

• Manage comprehensive document control processes.
• Generate Prescription Labels for Mighty Oaks Product ensuring compliance with MDD and MDR qualifications.
• Implement supplier evaluation process to maintain high standards of product quality and reliability.
• Collaborate cross-functionally with team members from areas including but not limited to Manufacturing, Engineering, Operations, and Regulatory Affairs.
• Author and revise numerous quality assurance procedures, regulatory documents, and training procedures for continuous improvement.
• Knowledge of medical device regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485:2016).

• Performed and reviewed First Article Inspection (FAI) and Receiving Inspection on incoming materials.
• Managed and maintained accurate calibration and preventative maintenance records for over 100 pieces of measuring and test equipment/fixtures, ensuring compliance with industry standards.
• Verify that materials, parts and assemblies procured meet dimensional and visual characteristics as required by Standard Operating Procedures, Manufacturing Assembly Instructions, Work Instructions, Drawings.
• Initiated and evaluated nonconformance material reports within the manufacturing department.
• Inspected 3D Printed Parts and Bone Models.
• Maintained documentation for medical device history records.

Kansas City, Missouri, United States

• File documents, print and collate client packets for meetings, and create product packets for luncheon meetings (up to 50 attendees). Set appointments for financial advisor staff.
• Utilize MS Excel, sorting clients by vendor, for notification of conversion to online report distribution.
• Utilize MS PowerPoint to create various presentations for financial advisor staff.

Wichita, Kansas Metropolitan Area

• Created new design of pedicle rod screw for spinal surgeries offering enhanced stability in correction of spine misalignment. First class performing senior design project remotely due to COVID. o Current pedicle rod.
• Performed 3D printing of pedicle rod screw, with theoretical printer model and adjustments for stress test issues, all simulated online for viewing to ensure deformations were corrected.
• Won numerous awards at Engineering Open House, including: o Outstanding Manufacturing Engineer Project-2nd Place, 2021.o 2nd Place Overall BME Department, 2021.o Most Entrepreneurial, 2021.
• Determined strategic focus of project (mission and vision statement), crafting a “needs statement” consisting of issue, why product need improvement, and specifics of project in addressing problem.
• Performed gap analysis of current state, desired state, identified gaps, and gaps due to features, properties and proper functioning, and methods used to identify gaps.
• Capstone One: Possible Senior Design Projects, three-minute presentation--Introduction to Updated Pedicle Screw Design, four-minute presentation.

Lees Summit, Missouri, United States

• Interacted with customers to locate clothing and computerized invoices, advised clients as to issues with cleaning (stains) and notified management and laundry.
• Provided heat sealed tags for each client clothing items for tracking, detailing client contact info and item.
• Trusted to open and close store, including alarm code and cash register reconciliation.
• Created tickets for alterations, specifying exact measurements to tailor and client contact information.
• Inventoried all cleaning in store and matched it to computer invoicing.

B.S. Biomedical Engineering

Engineering Economy Course

During summer 2019, I completed engineering economy abroad in Rome, Italy. Showcased learning orientated mindset in a foreign location..