Sara Wallace

Background

About Sara Wallace

I have 14+ years of career experience in scientific research and Medical Device Manufacturing Quality Assurance, R&D, Tech Support, and Technical Writing. My greatest strengths lie in my abilities to problem-solve, successfully develop and execute comprehensive projects, optimize processes & campaigns, create great communications, and connect cross-functional resources for the benefit of all. CAREER HIGHLIGHTS: Experience: 9+ years combined in cGMP, ISO13485, and ISO9001 Medical Device Development & Manufacturing- Quality Assurance Processes including QMS/TQM, Continuous Improvement, CAPA, Risk Management, Internal Audits, Software/Database Validation, Change/Compliance Implementation, and Data Integrity - Product R&D, V&V, Data Analysis, Design Control, Technology Transfer, Change Control, & New Product Introduction (NPI)- Technical Communications & Design: SOP, CAPA, Training, & Auditing Materials, Marketing Collateral, Visual Workplace, etc- Lean Manufacturing, QC Test & Pass/Fail Criteria Design, Batch Record Review, Failure Investigation, Receipt of Incoming Materials, Equipment Maintenance - Customer Support & Complaints Tracking, Internal/External Training Strengths: I thrive where I can work hard on many projects, support innovation and optimization, and help empower others. I enjoy exploring ideas and building systems to organize work and people, problem-solving, writing, presenting, and training. Major Accomplishments- Played a key role in Quansys' successful transition to ISO13485 & cGMP from ISO9001, helped redesign/author/update policies, processes, metrics, process controls, trainings, documents etc- Singly designed and managed the 1st Technical Customer Support program at Quansys- Recently nominated to lead a site-wide ISO 13485:2016 "Data & Metadata Governance" compliance gap analysis at GE Healthcare Cell Culture. For further info, check out my resume below, or contact me via Linked Messaging.