Antonio Pickenpack

Managed medical device risk management and quality compliance for SaMD, including requirements analysis and design controls using 21 CFR Part 820/Part 11, ISO 13485, and ISO 14971. Developed QMS and SDLC/PDLC quality artifacts for FDA De Novo submissions, managed Greenlight Guru-based DMR/DHF, and implemented NCR/CAPA, quality review metrics, HIPAA (45 CFR) compliance, and laboratory validation an

Supported medical device risk management and quality compliance for the Abbott Alinity diagnostic platform, applying 21 CFR 820, ISO 13485, and ISO 14971. Contributed to EU IVDR technical file development, including GSPR and viral inactivation statements for notified body submission documents.

Executed risk assessments and supported regulatory documentation for MDR technical submissions for SaMD and combination products, using 21 CFR Part 4, ISO 14971, ISO 13485, and MDSAP standards. Designed and implemented the EU MDR 2017/745 risk assessment process, supported design transfer/DHR-DMR verification, and contributed to remediation and quality record change management using TrackWise 8 an

Led medical device process validation activities (IQ/OQ/PQ) and project planning for device lifecycle requirements, ensuring compliance with 21 CFR 820, 21 CFR Part 11, 21 CFR Part 211, IEC 60601, and ISO 14971. Built OQ test cases for Cat-4 software hand-off to engineering teams and supported design transfer/verification and production operations inspections and testing in line with cGMP.

Provided risk management and compliance support using SOX, FFIEC, and COBIT frameworks, performing controls verification and controls testing across banking applications and services. Supported SOX audits including SOX 404 remediation, executed GRC ITGC risk assessments and testing with RSA Archer, and managed agile SDLC remediation project planning including schedules, resources, and WBS.

Managed global IT risk management and regulatory compliance, including QMS audits for medical device and IT suppliers, and ensured adherence to FDA Quality Systems Regulation (QSR). Designed and implemented internal audit programs, led supplier quality agreements and ISO/21 CFR-aligned supplier audits, and supported QMS improvements via NCR/CAPA, metrics reporting, HIPAA control assessments, and c

Managed a team of four software process consultants to develop and implement SDLC process methods aligned to SEI CMM(SW)(I) maturity goals, including internal audits to ensure compliance. Delivered process optimization that achieved 15% business-value-added savings and supported Agile/RAD/hybrid and waterfall delivery approaches along with configuration and change management.

Led QMS audits of internal and vendor IT products and services supporting manufacturing, medical device, and laboratory applications, focusing on software products used in regulated environments. Created and implemented strategic processes for management and evaluation of IT suppliers, ensuring compliance with ISO 9001/ISO 13485, COBIT, SEI-CMM, PDA standards, and FDA GxP CFR requirements.

Master of Business Administration (MBA) in Management from the Brennan Graduate School of Business.

Bachelor of Arts (B.A.) in Philosophy, with a minor in Computer Science.