Christa Nova Email & Phone Number

St Louis, Mo, Us

Summary of RoleOverseeing and managing the Quality Management System (QMS), regulatory affairs, risk management, and consultant services while leading a team of quality and regulatory professionals to ensure compliance and operational excellence.Job Functions* Management Representative - oversees the quality management system (QMS), ensuring its effective implementation and addressing issues as they arise.* Quality Assurance Lead - leads the QA team in the development and maintenance of the Quality Management System (QMS), and supports its implementation across the company. Manages document control, supplier relationships, operations support, and employee training. Oversees computerized systems, leads internal and external audits, and stays updated on quality requirements.* Document Control Lead - manages the release and change control of all documentation within the document control system. Oversees document control activities, and coordinates and tracks employee training.* Regulatory Affairs Lead - leads the RA team in meeting compliance deliverables and managing all regulatory efforts. Oversees regulatory submissions, registrations, licenses, and ensures adherence to current regulatory requirements.* Risk Manager - Manages all risk management activities, including the development and maintenance of Risk Management Files (RMFs). Identifies, analyzes, and mitigates risks related to medical devices, ensuring compliance with applicable regulations and standards.* Department Manager - leads and manages a team of quality and regulatory professionals, overseeing training and onboarding, quality assurance, document control, corrective and preventive actions, supplier management, computerized systems validation, and regulatory affairs.* Consultant Management - manages external consultants providing quality and regulatory services, ensuring their alignment with company standards and project objectives.

St Louis, Mo, Us

Summary of RoleLead regulatory efforts and keep abreast of regulatory requirements.Additional Training:• Survivor: The FDA 510(k) Program Edition through RAPS with DuVal & Associates, RQM+, Galvanize Therapeutics, and US FDA CDRH (November 2023).• Medical Device Software Development Life Cycle Training (IEC 62304) through Oriel Stat A Matrix (April 2024).

Los Angeles, California, Us

Company SummaryManufacturer of software-driven and machine-learning cerebral ultrasound medical devices to capture blood flow data in real-time to identify brain illnesses and diseases.Summary of RoleContribute to complex submissions and technical files for US FDA 510(k), Health Canada licence, and EU CE mark products in accordance with regulatory requirements.Job Functions:• Perform internal audit to QMS, FDA QSR 21 CFR 820, Europe MDD, ISO 13485:2016, Canada SOR/98-282, and MDSAP.• Prepare and submit Amended Class III Medical Device Licence to Health Canada• Prepare and submit New Class III Medical Device Licence Application to Health Canada• Prepare and submit (Laser) Annual Report to FDA• Review and provide feedback (Regulatory Impact Assessments) for engineering, labeling, and product CAPAs, NCMRs, and other documentation for compliance according to the US and international regulatory requirements.• Review and update product labeling database (FDA GUDID) to ensure conformance with regulatory requirements and/or approved product claims.• Review and provide feedback and guidance for product advertising to ensure compliance with global labeling requirements.• Manage plan, checklist, and report for international field action.

Bryan, Oh, Us

Company SummaryManufacturer of ultraviolet light-emitting phototherapeutic medical devices to treat specific skin conditions such as psoriasis, vitiligo, and eczema (atopic dermatitis).Summary of RoleCreate, manage, and audit for regulatory requirements including document and process controls for ISO 13485:2016, FDA 21 CFR Part 820 QSR and 510(k), EU MDR, Japan PMDA, Korea KFDA/MFDS.Job Functions:• Onboard new hires with developing Training Action Plans and providing regulatory and quality training.• Manage document/process control through all departments to develop and release documentation that meets National and International standards, risk management, biocompatibility, usability, and more.• Manage the Heat Treat Lumber process including participating in third-party audits and maintaining physical records and online data.• Audit and file work orders, service reports, and electronic documentation.• Track customer feedback and develop appropriate reports.• Perform internal audits throughout the company and participate in external audits as needed.• Update regulatory documentation as needed, Design History File (DHF), Device Master Record (DMR), Device History Record (DHR) as well as Technical files (TF).• Assist with federal, state, and international regulations.• Aid in development and updates for labeling of medical devices.Additional Training:• Quality Management System Internal Auditor (ISO 9001:2015) inclusive of ISO 13485:2016 through Oriel Stat A Matrix (November 2020).• Quality Management System Training for Medical Devices: FDA QSR and ISO 13485:2016 through Oriel Stat A Matrix (November 2020).

United States, Fully Remote, Us

Member of the online education marketplace, Outschool. Create and deliver an interactive online class for a variety of topics and students.

Responsible for lab protocols, standards, customer protocols, calibration program, external products and services, intralaboratory comparisons, lab activity analysis, complaint process, risks and opportunities process, improvement process, templates, all customer and lab documentation and records, maintaining the intranet, website, emails, phone, calendars, and more.

Archbold, Oh, Us

• Collect, update, and maintain compliance data in the compliance database. • Aid in monitoring state and federal regulatory entities, publications and legislation.• Request and evaluate customer specific performance requirements and third party protocol.• Create reports and provide support with compliance data• Coordinate efforts to understand and communicate appropriate personnel of changes and additions to state and federal regulations and customer-specific protocols.• Create test applications for third party testing.• Review, document, and file third party reports.• Assist in resolutions to issues related to purchased part non-compliant reports.• Assist in resolutions to non-compliant test reports.• Communicate with third party test labs to understand and resolve issues, understand new requirements and update Sauder Woodworking Co processes and procedures when necessary.• Assist Sauder Manufacturing, Progressive, SGS and other subsidies with use of the compliance database.• Create and maintain SharePoint sites and pages for compliance and product improvement.Additional Training:• Microsoft Access 2016 Intermediate and Microsoft Visual Basic Applications 2016 through Custom Training Solutions of NSCC by Grayling Lathrop• ISO/IEC 17025:2017 The New Standard for Laboratory Competence Course through A2LA WorkPlace Training by Rob Knake

Archbold, Oh, Us

• Communicate electronically with retailers to build and strengthen lasting relationships with each individual contact by providing timely, friendly, courteous and expert service.• Respond promptly to retailer inquiries.• Interview retailers to obtain information and explain available services.• Provide retailers with product, warranty, assembly, and repair part information.• Investigate and correct errors, utilizing consumer and company records.• Interpret blueprints to aid discussion with consumer / retailer in order to advise and resolve assembly issues.• Resolve or refer management to necessary complaints concerning services and product failure.• Recognize, document, and alert Consumer Services Director of trends in retailer contacts and make suggestions for changes or improvements.• Document and inform management of product related incidents in which product and/or household damage and/or injury occurred and may provide recommendation for course of action.• Coordinate consumer / retailer service needs with other departments as required to assure customer service.• Acquire and maintain knowledge of past and current product line.

Archbold, Oh, Us

• Supported manufacturing processes in identifying quality issues, root cause, and corrective actions. • Read, interpreted, and applied quality specification standards to manufactured and supplied materials.• Worked directly with leadership and specialists to enhance the quality of processes. • Lead and assisted in the implementation and ongoing support for the quality of processes.• Collaborated with other Manufacturing Technicians to improve processes and quality control.• Analyzed performance data generated from internal defects and customer complaints and report to process leadership group on root causes and improvement opportunities.• Encouraged and promoted quality improvements company-wide through continuous improvement initiatives. Additional Job Functions or Training:► Department: Softform and ContourNovember 2015 – October 2017• Undergone training in Control of Hazardous Energy (Lockout/Tagout)• Participated in a 2-day Lean Coaches Training event in Soft Skills• Trained in Core Level Edge Treatments (40hrs) and Core Level Boring Machines (40hrs)• Attended Leadercast 2016• Co-led LEAN 5S events for production lines.• Created and conducted training for new feature across multiple departments.• Attended 'Internal Audits - Simple and Effective' seminar through NWOQC by Dwight Lee Bergman• Attended 'Dashboard with Excel' webinar taught by Mike Thomas.• Trained in Intermediate Excel 2013 and Basic Access 2013 through Custom Training Solutions of NSCC by Jolene Sigg► Department: Final Assembly, Hardware, and Instruction BooksJuly 2015 - November 2015• Supervised a team of 15+ final assembly quality representatives in quality tasks• Created onboarding quality training for new pack associates • Regularly visited the packaging supplier with the packaging engineer to learn about package design and test and influence packaging decisions for final assembly.

Archbold, Oh, Us

• Worked directly with managers and leaders throughout the manufacturing processes in value streams including Edgeband, Small Parts, Final Assembly, Contour, Softform, Scheduling, and more. • Practiced various management skills, including: being part of an interview team, conducting tasks in time and attendance, auditing, visual management, safety and sustainability, quality, and more. • Participated in a 5S event with Auxiliary Services and participated in a Kaizen event on the topic of warehousing leftover parts from packing.• Shadowed management from the ground up (group leaders, area leaders, process leaders).• Studied through the Gemba Academy and learned about Lean Manufacturing and its tools, including flow, standardized work, quality at source, visual controls, quick changeover, value stream mapping, and more.

STEAMer Trunks was a monthly subscription service providing educational and experiential activities for children developmentally aged three years to school age to strengthen their relationship with their seven senses and enhance their Science, Technology, Engineering, Art/Design, and Mathematics (STEAM) skills.Responsibilities:• Product research and procurement• Graphic design utilizing Gimp, Inkscape, and Adobe programs• Layout design using Adobe programs• Graphic attainment involving working with artists• Inventory management utilizing Zoho web-based databases• Warehousing and shipping• Marketing research and development, including advertisements and target market analysis• STEAM research and activity testing

• Provided excellent customer service• Organized and maintained a records system• Used QuickBooks to maintain vendor and customer files• Prepared correspondence, bills, vehicle information lists, and special projects• Managed online sales including photography, information, and advertisements • Created a work order system using Word, scheduling system using Excel, and technical worksheets using Word

Philadelphia, Pennsylvania, Us

• Trained vault attendants • Head of three cash vaults at four events centers• Provided administrative support to Office Manager• Maintained vendor files, medical files, and employee files• Keyed accounts payable entries and statement reconciliation• Securely handed out cash bags and accurately counted all incoming cash bags • Balanced safe at start and end of each event and made change runs as needed • Prepared starting banks, Excel spreadsheets, cashier reports, and input data into Excel reports throughout events• Completed Training for Intervention ProcedureS training and became certified• Completed ServSafe® training and became certified for handling food and alcohol

Bachelor’S Degree, Business Administration

Associate Of Applied Business In Office Administrative Services, Office Management