Andrew McDermott
Indianapolis
Summary
Results-oriented professional adept at creating and implementing protocols and supervising risk management adherence to foster conformance to company quality standards. Strong aptitude for identifying risks and implementing actionable initiatives to improve the quality system.
Overview
7
7
years of professional experience
4
4
years of post-secondary education
1
1
Certification
Work History
Quality Engineer
PTS Diagnostics
05.2021 - 12.2025
- Risk management process owner
- Lead Risk management activities during BSI and FDA audits
- Analyze post market trends for product and patient risk
- Lead cross functional team to review current and potential risk
- Collaborated with regulatory affairs being an IVDR team member for product submissions
- Led product research submissions for regulatory gaps for temperature and humidity studies
- Devolved engineering protocols for product limits of detection
- Train QC scientist on laboratory procedures, data collection, and product defect analyst
- Responsible for facility water testing and analyst
- Develop new protocols for laboratory equipment
- Execute NCR and CAPA activities for closure
- Create and Preform research documentation on product specification gaps
Quality Analyst
Baxter International
02.2020 - 05.2021
- Ensure standards for client audits, FDA regulations and Baxter quality is met
- Evaluate a proper course of corrective action dealing with errors and discrepancies
- Collaborate between clients, project management, and Baxter for product shipment
Manufacturing Associate
Catalent Pharmaceutical (Novo)
Bloomington
02.2019 - 02.2020
- Adhere to CGMP guidelines and regulations
- Fulfill standard operating protocols for drug product manufacturing
- Problem solving with team to accomplish client orders
Education
Bachelor of Science - Chemistry
Ball State University
Muncie, IN 08.2011 - 08.2015
Skills
- Risk management
- Regulatory affairs
- Product testing and research
- Laboratory procedures
- Data collection
- Product defect analysis
- Water testing
- CAPA activities
- Research documentation
- Quality standards adherence
- FDA regulations
- Error and discrepancy resolution
- Collaboration with clients and project teams
- Manufacturing protocols
- Problem solving
Title
Quality Engineer/Scientist
Certification
- Design Control Requirements Integrating The Quality System ISO 13485 - AAMI
- Risk Management For Medical Devices - Leap Compliance
- Reviewed and released one of the first Covid vaccines during the pandemic - Baxter
Timeline
Quality Engineer
PTS Diagnostics
05.2021 - 12.2025
Quality Analyst
Baxter International
02.2020 - 05.2021
Manufacturing Associate
Catalent Pharmaceutical (Novo)
02.2019 - 02.2020
Bachelor of Science - Chemistry
Ball State University
08.2011 - 08.2015