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.

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%

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

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.

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)

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