Vice President Quality Assurance & Control

Dynamic Quality Management and Regulatory Affairs executive with over 22 years of experience in global quality operations, compliance leadership, and crossfunctional team management

Expert in ISO 13485, FDA 21 CFR 820, J-PAL, MDSAP, MDR, IVDR, and GMP environments, ensuring regulatory excellence for medical devices and IVDs

Proven track record in leading large-scale international teams, achieving audit readiness, and implementing innovative quality systems to enhance efficiency and compliance

Skilled in fostering cross-functional collaboration to align quality objectives and regulatory compliance with business growth, driving operational excellence and product quality

Leading the Global Quality and Regulatory Affairs Team with direct reporting to the CEO

Spearheading IVDR compliance for Class C in-house and CE IVDs, securing regulatory approvals in the U.S., LATAM, Canada, and Asia

Chairing Global Quality Board, ensuring QMS compliance with ISO 13485, ISO 27001, GCLP, CAP Lab Accreditation and ISO 15189

Managing the Joint Venture project of successfully establishing a QMS for a genetic lab in Saudi Arabia

Streamlining audit processes, reducing preparation time by 30% and improving supplier oversight

Established strategic alliances with pharma partners, ensuring alignment of customer-related requirements and quality initiatives

Directed global quality teams (200+ FTEs) across EMEA, Asia, and the Americas, supporting the vaccine industry

Establishment of global product inspection and validation guidelines

Implemented global GMP, MDSAP, MDR, and IVDR requirements, ensuring seamless regulatory compliance

Established sterilization validation protocols (gamma, ETO) and harmonized laboratory processes worldwide

Harmonization of global quality and operational processes

Improved CAPA effectiveness, reducing open and overdue issues through enhanced tracking systems

Person Responsible for Regulatory Compliance (Article 15, MDR 2017/745 and IVDR 2017/746)

SAP implementation of Engineering Change Request and Nonconformity Management

Recall and FSCA management

Establishment of standardized material database for medical devices

Distributor and Supplier Management

Stage Gate Reviews for new products

Primary interface to Operations, Product Management and Global Regulatory Affairs

Managed post-production quality operations for global distribution centers (25+ team members) in Europe, Asia, Americas

Implemented MDR 2017/745 requirements for risk management, Post-Market-Surveillance, and supply chain processes (Stream Lead)

Built relationships with Notified Bodies and ensured timely certification renewals for global markets

Reduced adverse event closure times through streamlined complaint handling processes

Budgeting and global resource management

Escalating quality issues to Senior Management

Lead Auditor for internal, intercompany and distributor audits

Recall and FSCA management (Leader of FSCA Board)

Support for sales and marketing organizations in quality related inquiries and quality issues with customers and distributors

Collaboration with Global Regulatory Affairs, Risk Management, Clinical Trials Management department and Operations (different production sites in U.S. and APAC region)

Leading the Operations Quality Assurance Team

Establishment of Engineering Change Request (ECR) Process for sustaining engineering, product care and product improvement

Implementation of processes into new QMS

Lead Auditor internal and supplier audits

Responsible for budget and forecast planning

Management of Nonconformity handling and CAPA escalation

Management of Computerized Software Validation activities (CSV) and maintenance of validation masterplan for GxP software

Quality Dashboard Leader for Supply Chain and Operations

Supplier control including associated quality agreements

Interface between operations and R&D for software lifecycle activities

Definition of and employee training for SAP workflows concerning quality events in production

Quality Representative & Head of Quality Assurance Supply Chain Capital Equipment reporting to CEO and into Getinge Global Quality Organization

Leadership responsibility for the Quality Management Team and the Quality Assurance Department

Maintenance and improvement of QMS according to 21CFR 820, EN ISO 9001, EN ISO 13485 (+ Canadian CMDR) and JPAL

Implementation of Global Quality Directives

Lead of Global CAPA board

Establishment of KPI database and dashboard for reporting to Top Management

Annual Management Review

Lead Auditor internal and supplier audits

Interdepartmental cooperation with Regulatory Affairs dept

Contributed to medical device approvals for class I and IIa (EU) / II (FDA)

Director Corporate Quality and Security Officer for medical devices produced or distributed

Member of Executive Board

Technical and leadership responsibility for the QM/Regulatory Affairs Dept. and Supply Chain Team

Ensured QMS compliance with EN ISO 9001, EN ISO 13485 (+ Canadian CMDR) and US FDA 21CFR 820

Management Review and Audit Management

CE conformity assessment of medical devices class IIa, CMDCAS (Health Canada), FDA 510(k) notification

Software design processes according to IEC 62304

Optimization of process interfaces to CAPA and risk management including software bug list handling

Planning and coordination of usability studies and review of usability files according to IEC 62366

Process validation (DQ, IQ, OQ, PQ) for hardware and software-related processes

Quality Representative managing the QMS according to EN ISO 9001 and EN ISO 13485

Implementation of electronic document control system

Bi-annual Management Review and weekly quality reports

From 2004 additional responsibility as risk manager processing product-related risk analysis according to ISO 14971

Compilation of technical file for medical device class I and declaration of conformity in accordance with medical device directive 93/42/EEC

CAPA and Customer Complaint Management

Company-wide quality training

QC processes for the repair and maintenance of IVD lab systems

Implementation of machine directive 2006/42/EC and associated standards DIN EN ISO 12100 and DIN EN 14121 for effected devices

Foundation and leadership of a quality assurance department (4 members) and definition of quality control methods and corporate quality standards