ERIKA LUSK

• Spearheaded enterprise-wide QMS harmonization initiative across 45 global medical device facilities, integrating multiple quality systems into a unified, compliant framework aligned with ISO 13485, 21 CFR Part 820, and international regulatory requirements.
• Designed and implemented a standardized global Change Management process and risk-based QMS training framework, strengthening regulatory compliance and inspection-readiness across the enterprise.
• Led technical writing and change management for a multi-phase global QMS harmonization initiative across 45 medical device facilities; completed Phase 1 authoring of 29 regulatory- compliant global SOPs and work instructions and 12 training decks aligned with ISO 13485 and 21 CFR Part 820, and assessed 417 controlled facility documents (135 revised, 282 obsoleted), achieving a 68% reduction in QMS document footprint.
• Coordinated and mentored cross-functional global teams, managing project timelines, task trackers, and stakeholder communications to drive on-time delivery of a multi-million dollar QMS initiative across 45 facilities.

• Developed and implemented enterprise-wide QMS and regulatory affairs training programs, building employee competency in quality systems, compliance requirements, and regulatory standards across a global workforce.
• Produced eight interactive electronic training modules covering key quality and regulatory concepts, improving training consistency and accessibility across multiple facilities.
• Co-led external audit backroom operations, coordinating documentation retrieval, organizing compliance records, and preparing SMEs across multiple facilities for regulatory inspection.

• Served as Design Controls SME for multiple surgical device projects, leading design history file development and change control activities in compliance with 21 CFR Part 820, ISO 13485, and EU MDR requirements.
• Conducted 14 internal audits as a qualified internal auditor, identifying quality system gaps and driving corrective actions to improve external audit outcomes and overall QMS performance.
• Pivoted rapidly during COVID to IVD EUA requirements, producing initial DDF documentation within eight weeks and collaborating on pre-EUA and EUA regulatory submissions for a COVID-19 diagnostic device under accelerated timelines.
• Developed and delivered internal training on design controls, change control, and data collection best practices, driving team compliance with QMS requirements.
• Drove design verification and validation efforts, ensuring quality system requirements and design inputs were met throughout the product development lifecycle.

Progression: Research Chemist (2006) → Analytical Chemist (2009) → Senior Analytical Associate Scientist (2011) → Scientist/Project Leader (2015)

• Supported QMS compliance and quality documentation efforts for the MiStent® Sirolimus Eluting Stent (Class III combination product) across a 12-year development-through-commercialization lifecycle.
• Directed ICH stability program in compliance with QMS and regulatory requirements, overseeing protocol development, vendor management, data analysis, and documentation of study results.
• Collaborated with contract manufacturing organization to qualify analytical lab instrumentation, producing qualification protocols and documentation for raw materials and in-process testing to
  support QMS compliance.
• Developed and optimized analytical methods and supporting quality documentation for API
  content testing, ensuring alignment with QMS and regulatory standards.