ANGELA KARJALA
Bemidji,USA
Summary
Multidisciplinary professional with expertise in biomedical technology, quality systems, and information technology management. Known for creatively integrating digital tools into regulatory and training workflows, enhancing compliance, and driving innovation in healthcare and med-tech environments. Adept at bridging technical know-how with human-centered process improvement.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Learning Quality & Technology Specialist
Philips
05.2022 - 05.2025
- Administers compliance training assignments across various business units, regions, and functions, ensuring all assignments align with learning standards and regulatory requirements.
- Executes improvement projects, initiate changes, and drive enhancements within the training administration discipline, continuously optimizing processes and achieving better outcomes.
- Works under limited supervision and broad guidelines, regularly applying independent judgment on matters of significance to drive project success and compliance.
- Develops and implements standardized roles and curricula within the TEDS Learning Management System (LMS), ensuring consistency in training standards and practices throughout the organization.
- Supports the creation and maintenance of relevant processes, work instructions, forms, and templates essential for managing the learning process, ensuring consistency and compliance across all training activities.
- Provides extensive support for learner and manager requests related to training assignments, progress tracking, and technical assistance, ensuring prompt and effective resolution of all issues.
- Trains and mentors junior administrators to ensure effective team performance, facilitating knowledge transfer and fostering a collaborative and high-performing team environment.
- Supports LMS validation and maintenance activities to uphold system reliability, functionality, and compliance with industry standards, ensuring the LMS operates efficiently and effectively.
- Collaborates with local Business Process Owners (BPO) and local content owners to implement and customize learning requirements based on regional or functional needs, ensuring relevant and effective training delivery.
- Generates, analyzes, and presents detailed reports on training compliance and key performance indicators (KPIs) to stakeholders, providing valuable insights for continuous improvement and strategic decision-making.
- Applies specialized knowledge in breadth and/or depth to a variety of issues and projects within the team, ensuring effective solutions and innovative approaches to complex challenges.
- Serves as a Business/Region/Function QMS Training Subject Matter Expert (SME) in Internal and External Audits and Inspections.
Quality Specialist
ALKU
11.2019 - 01.2020
- Reviewed and analyzed product complaint data and associated complaint investigation data, patient safety/clinical data, FMEAs, severity/harms assessment data, to identify Failure Modes and determine whether the complaint was an MDR Reportable Event to the FDA.
Quality Systems Specialist
Nuvectra
07.2019 - 11.2019
- Supported Quality Management System operation within organization.
- Ensured compliance with applicable government regulations and company quality assurance standards.
- Updated QMS procedures. Performed receiving inspection and functional testing activities.
- Initiated and dispositioned Non-Conformance Reports.
- Onsite Calibration Coordinator.
Business Process Analyst
Private Real Estate Group
08.2018 - 07.2019
- Defined business models and processes.
- Used social media and internet marketing tools, alongside Customer Relationship Management (CRM) systems to promote and manage personal business.
- Prepared presentations, reports, and contracts for clients.
- Explored and fine-tuned my customer service skills with clients and vendors.
Post Market Surveillance Analyst
Philips
04.2015 - 09.2018
- Worked on the Design Assurance team that brought our product to the market. Had the opportunity to fill multiple roles during the product development life cycle for our product, which included: Training Coordinator, Learning Management System Administrator, Product Analysis Lab Manager, Post Market Surveillance Analyst, and Calibration Coordinator.
- Worked within the following processes and systems: Process/Software Validations, Premarket Approval Readiness, Risk Management, Complaint Handling (Commercial and Clinical Complaints), CATSWeb, Medical Device Reporting, User Training, SumTotal, Clinical Trials Safety Database, EHS procedures, Documentation Control, Agile, and HR on-boarding process.
- Supported Internal and External Audits, along with being the Subject Matter Expert for Complaint Handling and Training.
Education
Bachelor of Science - Information Technology Management
University of Minnesota Crookston
Crookston, MN12.2023
Associate of Science - Biomedical Technologist
Anoka-Ramsey Community College
Coon Rapids, MN05.2013
Skills
- Articulate Storyline
- Document Management
- System Administration
- ServiceNow
- Project Management
- Microsoft Office
- Process Improvement
- Analytical Skills
- Windchill
- TEDS
- Mondaycom
- Smartsheet
- SharePoint
- Qlik Sense
- SAP BusinessObjects
- Requirements Analysis
- System Testing
- Global LMS Administrator
- Global Delivery
- Subject Matter Experts
- Regulatory Compliance
- Audit Support
- Learner support
- EDI
- Data Analysis
Certification
- Certificate in Quality Systems for the Biomedical Industry - May 2013
Timeline
Learning Quality & Technology Specialist
Philips
05.2022 - 05.2025
Quality Specialist
ALKU
11.2019 - 01.2020
Quality Systems Specialist
Nuvectra
07.2019 - 11.2019
Business Process Analyst
Private Real Estate Group
08.2018 - 07.2019
Post Market Surveillance Analyst
Philips
04.2015 - 09.2018
Associate of Science - Biomedical Technologist
Anoka-Ramsey Community College
Bachelor of Science - Information Technology Management
University of Minnesota Crookston
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