Lori K. Lam
Las Vegas,NV
Summary
Dedicated and results-driven recent nursing graduate with a proven track record in regulatory compliance, quality assurance, and process improvement. Seeking a challenging and fulfilling patient-centered nursing position to apply analytical and critical thinking skills. A collaborative team environment is desired to provide compassionate and high-quality care.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Product Compliance Specialist
Thermo Fisher Scientific Inc.
05.2019 - 12.2023
- Developed and maintained compliance tracking, metrics, and training materials for global business units.
- Managed global regulatory compliance (RoHS, REACH, CE Marking, MDR, Brexit, etc.) to ensure compliance and prevent 23 million revenue loss.
Sr. QA Specialist
Pharmacyclics (PCYC)
04.2017 - 02.2019
- Trained 10 employees on quality standards
- Regularly updated leadership on quality metrics, highlighting consistency issues and production deficiencies.
Regulatory Compliance Analyst
Stryker Endoscopy
10.2015 - 10.2016
- Collaborated cross-functionally (labeling, regulatory, product management, international teams) to resolve issues
- Successfully updated all Endo Stryker product Declarations of Conformity (DoCs) within deadlines to ensure timely European market access.
- Contributed to a major Technical File remediation project and participated in product recalls and audits.
Quality Specialist II
Acclarent (J&J)
01.2015 - 10.2015
- Successfully contributed to a new complaint-handling system migration
- Developed training materials and ensured compliance with post-market activities (evaluation, filing, reporting, and communication).
- Supported a successful audit by validating the system's live environment replication.
Quality Engineering Analyst II
Abbott Vascular
07.2014 - 12.2014
- Led complex failure investigations for Class III heart valve failure medical device
- Collaborated with engineers in new product introduction phases to develop and verify design changes.
Product Safety Specialist
InSound Medical (ISM)
06.2011 - 12.2012
- Independently launched and scaled a pilot clinical study program from 12 to 70 provider sites within three months.
- Oversaw all post-market product quality, safety activities, and performance tracking/reporting.
Product Analyst II, Post-Market Compliance
Boston Scientific (BSC)
06.2010 - 06.2011
- Oversaw global product surveillance for all company medical devices, focusing on quality, reliability, safety, and effectiveness.
- Collaborated cross-functionally to ensure compliant FDA reporting of serious adverse events and reviewed/approved product failure investigations.
Education
Bachelor of Science - Nursing
Roseman University of Health Sciences
Henderson, NV10-2024
Bachelor of Science - Health Sciences - Health Service Administration
San Jose State University
San Jose, CA05.2007
Skills
- Patient assessments
- CAPA
- Medication administration
- Excel Pivot Charts and graphs
- Vitals monitoring
- Meditech, EPIC & Cerner EMR software
- Medical documentation
- IV removal
- Infection control standards
- Privacy and confidentiality
- Time management
- Problem-Solving
Clinical Experience
August 2023 - October 2024
- Pediatric Nursing, Silver State Pediatrics - Skilled Nursing Facility, Las Vegas, NV
- ICU & ER, Valley Hospital Medical Center, Las Vegas, NV
- Labor & Delivery & Maternity, Southern Hills Hospital, Las Vegas, NV
- Psychiatric Unit, Rawson-Neal Psychiatric Hospital, Las Vegas, NV
- Medical/Surgical Unit, MountainView Hospital, Las Vegas, NV
- Pediatrics Unit, UMC Hospital, Las Vegas, NV
- Rehab, Encompass - Desert Canyon, Las Vegas, NV
Certification
- American Heart Association Basic Life Support (BLS) – American Heart Association.
Languages
Vietnamese
Native or Bilingual
Timeline
Product Compliance Specialist
Thermo Fisher Scientific Inc.
05.2019 - 12.2023
Sr. QA Specialist
Pharmacyclics (PCYC)
04.2017 - 02.2019
Regulatory Compliance Analyst
Stryker Endoscopy
10.2015 - 10.2016
Quality Specialist II
Acclarent (J&J)
01.2015 - 10.2015
Quality Engineering Analyst II
Abbott Vascular
07.2014 - 12.2014
Product Safety Specialist
InSound Medical (ISM)
06.2011 - 12.2012
Product Analyst II, Post-Market Compliance
Boston Scientific (BSC)
06.2010 - 06.2011
- American Heart Association Basic Life Support (BLS) – American Heart Association.
Bachelor of Science - Nursing
Roseman University of Health Sciences
Bachelor of Science - Health Sciences - Health Service Administration
San Jose State University
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