Ashley Kelleher

As the regional operations and strategy leader for the Medical Devices business in North America, I oversee the full operational, financial, and strategic performance of the portfolio. I lead AOP development, P&L execution, multi-year forecasting, pricing and margin strategy, workforce planning, competency modeling, customer experience alignment, and cross-functional coordination with Finance, Sales, Operations, and Global Leadership. My role centers on stabilizing operations, strengthening planning accuracy, modernizing workflows, and building scalable systems that support consistent growth and delivery performance.

Key Leadership Contributions:
• Lead the full AOP cycle, quarterly forecasting, pricing decisions, and margin management for the North America medical portfolio.
• Direct regional workforce strategy, including assessor and auditor onboarding, competency development pathways, and succession planning.
• Improve operational predictability by modernizing workflows, strengthening data quality, and aligning delivery systems with Finance, Sales, and global structures.
• Oversee customer experience strategy, ensuring communication frameworks, issue-resolution pathways, and delivery consistency across clinicians, assessors, auditors, and technical staff.
• Guide performance execution, utilization strategy, demand planning, and portfolio alignment with regional EBIT and revenue targets.
• Represent North America in global leadership forums, aligning operational expectations, competency requirements, and regulatory readiness across regions.

• Leveraged professional networks and industry knowledge to strengthen client relationships.
• Spearheaded innovative approaches to resource allocation and strategic planning.

Served as the program manager responsible for accreditation alignment, program governance, operational execution, and competency systems for NSF’s Medical Device and IVD programs. Directed accreditation activities with ANAB, developed controlled documentation, and strengthened internal systems through new procedures, work instructions, forms, and program controls. Managed auditor recruitment, onboarding, and competency development while ensuring operational readiness, delivery quality, and alignment with regulatory expectations.

Key Contributions:
• Managed all ANAB accreditation activities for medical device and IVD programs, including evidence submission, audit coordination, corrective actions, program documentation, and ongoing compliance maintenance.
• Created and updated program documentation, including procedures, work instructions, forms, and governance controls to ensure alignment with accreditation, regulatory, and internal quality expectations.
• Recruited, onboarded, and trained auditors and technical staff, ensuring competency, regulatory alignment, and readiness to support program growth and delivery needs.
• Strengthened program operations through improved workflow design, resource coordination, delivery consistency, and communication pathways across consulting, training, and operational teams.
• Supported interpretation and application of regulatory requirements (ISO 13485, ISO 14971, ISO 15378, QSR 820, GMP/GDP/GLP) to ensure consistent application across internal and external stakeholders.
• Enhanced program readiness and customer satisfaction by improving planning processes, delivery oversight, and issue-resolution pathways.
• Collaborated with senior instructors, consultants, and leadership to support competency development, regulatory alignment, and continuous program improvement.

• Maximized performance by monitoring daily activities and mentoring team members.

Served as a senior regulatory consultant and instructor delivering high-impact training and expert regulatory guidance to global medical device and IVD organizations. Developed customized programs, supported large OEMs and emerging manufacturers through quality system and regulatory challenges, and served as a subject matter expert across multiple standards and regulatory frameworks. Provided technical leadership to internal consultants while strengthening client readiness, audit preparedness, and operational maturity.

Key Contributions:
• Delivered specialized global training programs covering GMP, GLP, GDP, ISO 13485:2016, ISO 14971, ISO 15378, QSR 820, MDSAP fundamentals, FDA 483 response and inspection readiness, post-market surveillance, and medical device market and regulatory trends.
• Provided regulatory consulting and strategic advisory support to large OEMs, IVD companies, and regional manufacturers, including gap assessments, remediation planning, quality-system upgrades, and implementation support.
• Acted as an SME for medical device and IVD regulations, translating complex regulatory and technical requirements into practical, risk-based operational strategies for clients.
• Created tailored training curricula and regulatory education modules for enterprise clients to support compliance, operational capability, and organizational competency.
• Supported junior consultants and internal instructors through mentoring, calibration, and technical development to improve service quality and delivery consistency.
• Enhanced client satisfaction through improved communication, high-value regulatory guidance, and consistent delivery of actionable compliance and QMS strategies.

Served as a senior regulatory consultant and instructor delivering high-impact training and expert regulatory guidance to global medical device and IVD organizations. Developed customized programs, supported large OEMs and emerging manufacturers through quality system and regulatory challenges, and served as a subject matter expert across multiple standards and regulatory frameworks. Provided technical leadership to internal consultants while strengthening client readiness, audit preparedness, and operational maturity.

Key Contributions:
• Delivered specialized global training programs covering GMP, GLP, GDP, ISO 13485:2016, ISO 14971, ISO 15378, QSR 820, MDSAP fundamentals, FDA 483 response and inspection readiness, post-market surveillance, and medical device market and regulatory trends.
• Provided regulatory consulting and strategic advisory support to large OEMs, IVD companies, and regional manufacturers, including gap assessments, remediation planning, quality-system upgrades, and implementation support.
• Acted as an SME for medical device and IVD regulations, translating complex regulatory and technical requirements into practical, risk-based operational strategies for clients.
• Created tailored training curricula and regulatory education modules for enterprise clients to support compliance, operational capability, and organizational competency.
• Supported junior consultants and internal instructors through mentoring, calibration, and technical development to improve service quality and delivery consistency.
• Enhanced client satisfaction through improved communication, high-value regulatory guidance, and consistent delivery of actionable compliance and QMS strategies.

Led the development, operational alignment, and strategic expansion of DQS’s medical certification programs across North America while supporting global harmonization with DQS Med Germany. Oversaw accreditation activities, program development, competency systems, and regulatory alignment across multiple regions. Built accredited programs from inception, strengthened global operations, and served as a key technical authority across medical device and pharmaceutical standards.

Key Contributions:
• Designed and implemented the ISO 15378 (GMP for primary packaging materials) accredited program for North America, securing ANAB approval on the first submission within three months.
• Partnered with DQS Med Germany to harmonize ANAB and DAKKS frameworks for ISO 13485, ISO 14971, ISO 15378, GMP, GDP, GLP, MDR/MDD, and MDSAP programs.
• Developed global competency models, onboarding programs, training curricula, and authorization pathways that improved technical consistency across nine international offices.
• Served as Lead Auditor, Technical Reviewer, and Certification Issuer for ISO 13485, ISO 15378, ISO 14971, GMP, GDP, and GLP, ensuring accuracy and consistency in certification decisions.
• Conducted assessments as Lead Auditor for MDD, MDR, and MDSAP, supporting high-risk regulatory transitions for global manufacturers.
• Redeveloped auditor training and competency processes to meet ISO 17021 and IAF MD 8/MD 9 requirements, improving global program maturity and reducing variation.
• Strengthened operational alignment between North America and Germany through joint program development, regulatory interpretation, and cross-regional planning.
• Provided hands-on technical and operational leadership, enhancing program stability, training effectiveness, and global delivery quality.

• Developed and updated policies and procedures, maintaining compliance with guidelines relating to HIPAA, GDPR, as well as benefits administration and general liability.

Managed all accreditation activities, quality-system governance, auditor competency development, and operational oversight for a rapidly growing certification body. Led ANAB and IATF accreditation cycles, coordinated accreditation audits, managed findings, and ensured compliance with evolving ISO 17021 requirements. Oversaw auditor recruitment, onboarding, training, witnessing, and qualification while supporting cross-regional calibration with Turkey, India, and Asian offices. Built operational infrastructure, transitioned the organization from paper-based systems to digital workflows, and strengthened program effectiveness across all standards.

Key Contributions:
• Led all accreditation activities for ANAB and IATF, including planning, audit coordination, evidence submission, corrective actions, root-cause management, and ongoing compliance maintenance.
• Managed Jadian/IATF portal activities, auditor competency records, and compliance for all AS9100/AS9110/AS9120 and IATF 16949 accreditation requirements.
• Recruited, trained, onboarded, and qualified auditors across ISO 9001, AS9100 series, ISO 14001, ISO 45001, ISO 13485 (pre-DQS), and other industry programs.
• Designed and executed witness audits, monitored auditor performance, developed competency plans, and ensured calibration across domestic and international teams.
• Supported scheduling, travel planning, and operational coordination including visas, ITAR/security clearances, and international travel requirements for auditors.
• Collaborated with global offices (Turkey, India, Asia) to align training, auditing techniques, competency expectations, and program consistency across regions.
• Led the transformation from a paper-based system to a digital operational model, including building Salesforce auditor profiles, views, workflows, and training auditors on system use.
• Developed and maintained procedures, work instructions, forms, and internal audit programs to support accreditation readiness and operational structure.
• Served as internal point for technical questions, customer escalations, and program planning across multiple standards and accreditation scopes.

Oversaw the full auditor development lifecycle and operational planning functions for a large multi-standard certification body serving over 1,000 clients. Directed recruitment, onboarding, competency management, training, and witness audits across ISO, AS9100, food safety, ESG/GHG, and specialized programs. Led audit planning and full travel logistics across all standards and regions, ensuring accurate auditor assignment, competency alignment, and operational readiness. Supported accreditation activities for ISO 17021-1, 17021-2, and 17021-3 while partnering with sales and operations to support customer retention, new business growth, and seamless audit delivery.

Key Contributions:
• Managed end-to-end auditor lifecycle including recruitment, onboarding, competency tracking, training delivery, evaluation, and qualification across ISO, AS9100, food safety, and ESG/GHG programs.
• Oversaw full audit planning, scheduling, and travel logistics for a portfolio of 1,000+ clients, ensuring accurate auditor assignment, sector-code matching, and compliance with technical and regulatory requirements.
• Coordinated all travel and assignment logistics, including visas, international travel requirements, and ITAR/security clearances for auditors supporting global clients.
• Managed auditor application pathways and renewals through Probitas, RABQSA/Exemplar Global, and ASQ, guiding auditors from provisional through Lead Auditor status.
• Conducted witness audits, technical evaluations, and ongoing competency assessments to support accreditation readiness and compliance with ISO 17021 standards.
• Collaborated with sales teams to forecast auditor demand, identify sector needs, target recruitment, and support customer retention and new-business onboarding.
• Partnered with technical, operations, and planning teams to strengthen certification workflows, improve documentation accuracy, and ensure readiness for accreditation body audits.
• Developed training materials, supported internal training delivery, and calibrated auditor interpretation across programs to drive consistent, high-quality audit outcomes.
• Improved operational stability, increased auditor capability, and established robust development pathways that supported organizational growth and accreditation upgrades.

• Followed established auditing processes to meet internal and regulatory requirements.
• Identified control gaps in processes, procedures and systems through in-depth research and assessment and suggested methods for improvement.