Dana Yurach Email & Phone Number

London, Gb

Amsterdam, Noord-Holland, Nl

Promoted to lead, operationalize and sustain Quality Management and Audit function/teams across the business group; bring about cultural/quality transformation; manage inspections & certifications• Formulates and implements the Business’ long-range quality, regulatory and compliance policy & strategy• Enforces quality systems and harmonizes them across the Business sites and Sector/cluster.• Establishes and conducts an effective Management Review process, including routine reporting/monitoring.• Introduces and implements the IT systems & quality processes required for customer satisfaction/quality• Manages compliance to FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations.• Manages all inspections and questions relating to the operation of multiple global sites in coordination with all other applicable company groups.• Directs the Audit, Training, Software Validation, Data/Document & Change Control Programs.• Drafts and manages the strategic improvement processes (‘breakthrough Program’)• Interacts with all areas involved in the product development process, customer services and sales and marketing and provide direction and consultation

Amsterdam, Noord-Holland, Nl

Selected to form and lead a cross-functional high-performing team to address compliance challenges • Strengthened and improved the Quality System and CAPA program; achieved exceptional results• Drafted regulatory responses; ensured timeliness and completeness of corrective actions• Conducted Internal Audits to ISO 13485, MDD/IVDD, SOR/98-282, 21CFR Part11/801/803/806/820• Guided organizational units in addressing QMS deficiencies and resolving open issues• Closed substantial number of audit findings; exceeded goal contribution targets by >300%• Improved inspectional capabilities via creation and rollout of Inspection Management practices

Holliston, Ma, Us

• Leads and directs QA & RA across 15 global sites; develops and cultivates strategic plans & goals • Ensures that the company is in compliance with governing laws and regulations• Develops and controls quality programs, including production controls, change control, post market trend/data analysis, recalls, supplier management, deviations, internal audits, CAPA and complaints• Develops, implements, deploys efficient Quality Systems (multiple ISO 9001 & ISO 13485 certificates) • Maintains facility registrations and listings with Regulatory Authorities; hosts regulatory inspections • Prepares regulatory submissions in all geographies; sets regulatory compliance strategy• Active involvement in design control and operational/lean improvement projects; drives projects to goals • Implements consistent quality metrics across sites; leads Management Review meetings • Development & Maintenance of Quality Manual, risk management files, and technical files

Dublin, Ie

Leads the Medical Device QA function company-wide.Maintains Aptiv Solutions’ ISO 9001:2008 certification, hosts notified body audits as well as client audits.Medical Device/IVD/Combination product Quality Assurance Consulting including but not limited to:- Contract Management Representative within medical device companies (head of quality) - Supports and facilitates FDA, Notified body, WHO, and customer audits- Assists clients in preparing regulatory responses and addressing audit findings- Assists clients in Medical Device Reporting (Adverse Events) and Recalls- Audits companies for compliance with FDA QSR, ISO 13485 MDD, SOR/CMDCAS- Plans, manages, and implements quality system development and enhancement projects - Conducts supplier audits and assessments - Gap analysis and FDA / ISO 13485 readiness assessments- Assists client in selecting Notified Bodies and obtaining ISO 13485 certification

Milford, Ma, Us

Primary AccountabilitiesResponsible for Waters’ Laboratory compliance programs and business globally• Managing business unit offering laboratory audit/assessment services, equipment and IT systems validation and qualification services to bio/pharmaceutical and medical device companies• Lead Corporate Quality Systems Auditor (ISO 9001, ISO 13485, FDA: Quality System Regulations 21CFR Part820/801/803/806, 21CFR Part11) • Planning and conducting compliance audits to audit plan, exit meetings & final reporting• Developing SOPs and implementing Quality Systems, including software/product development lifecycle• Ensuring efficiency and effectiveness of processes (Lean Six Sigma project sponsor)• Managing a Product Management team and prioritizing efforts to meet business needs• Keeping current with regulatory/industry trends through networking, publications, and events Product Manager, Corporate Compliance Marketing (Laboratory Informatics) Primary AccountabilitiesDesigning software-based compliance products for the bio/pharmaceutical and medical device industries • Scope: All next-generation compliance products: Qualification, Validation, & Quality by Design• Understanding market/business needs, creating data products, influencing long term strategy• Managing suppliers, and leading global software development and evaluation teams• Developing supporting Quality Management processes and procedures• Lead Corporate Quality Systems Auditor (ISO 9001, ISO 13485, FDA: Quality System Regulation 21CFR Part820/801/803/806, 21CFR Part11) • Planning and conducting compliance audits to audit plan, exit meetings & final reporting

Marlborough, Ma, Us

Consulting Engagement

Tel-Aviv, Il

Milford, Ma, Us

Senior Development Engineer (Software & Device Quality) Primary Accountabilities• Managing the Quality Assurance evaluation (verification & validation) of diverse software/firmware and device structural validation projects to on-time and on-budget completion• Assigning workloads and managing team performance (project basis, up to 12 people)(And other roles)

Masters' Courses In Management, Marketing Management

Bsc, Chemistry

Education record