Anna Miedzinska

Performed 2nd party audits (supplier audits) for customers from various industry sectors, against ISO9001, ISO13485, and individual customer specifications.

Helping businesses transform to a new way of working. Specializing in business transformation consultancy, manufacturing transfers, process outsourcing, quality management systems, ISO13485, ISO9001, and pharmaceutical GMP.

Responsible for structuring and implementing supplier management processes, executing supplier audits, developing suppliers, training internal auditors, and supporting supply chain management and inspections.

Responsible for business relationship between Carmat and strategic Polish supplier.

Responsible for multiple workstreams within the QMS remediation project.

Part of the remediation project team.

Responsible for internal, corporate, and supplier audits. Cooperated with international regulatory agencies for submissions and product registration.

Managed the quality and regulatory aspects of the TFD group and the remotely based Quality Management Representatives for European regions.

Managed supplier quality aspects, created QA templates, and prepared and implemented MDR/IVDR related changes.

Delivered open and in-house training for ISO13485 and ISO9001. Performed audits for ISO13485, ISO9001, and MDD/MDR.

Performed supplier audits, internal audits, inhouse workshops, and training.

Performed 3rd party audits for certification bodies for InMetro Brazilian regulation, ISO13485, ISO9001, and MDD. Customers from various industries including food, electronics, and medical devices.

Served as an external expert for quality and regulatory compliance in the corporate End2End Q&R team. Reviewed new and redesigned processes for compliance, performed project management, and delivered internal training for ISO13485:2016 and ISO9001:2015.

Performed 2nd party audits (supplier audits) for customers like J&J, Bayer, Hospira, Baxter, against ISO9001, ISO13485, GMP, Pharma GMP (ICH Q7), and individual customer specifications.

Delivered public and in-house training for Lead Auditor and Internal Auditor for ISO 9001 and ISO 13485 (IRCA certified). Performed gap analysis, established action plans, and conducted internal, supplier, and mock 3rd party audits.

Responsible for all quality and regulatory activities for the site. Set up regulatory affairs strategy, established new processes for manufacturing, led quality system changes, and reported quality metrics to EMEA HQ.

Quality assurance responsible for day-to-day QA activities, managing CAPAs, compliance activities, NCMRs, and vendor quality. Led activities related to changing the quality system and implemented Agile electronic documentation system.

Managed chemical and packaging commodity suppliers for CardioVascular Galway division. Established supplier quality agreements, qualified new vendors, conducted supplier audits, and led supplier-related changes.

Responsible for process and product validation and manufacturing support. Reviewed and prepared validation documentation, coordinated validation testing, and generated Process and Design FMEAs.

Reviewed customer specifications and internal audits, cooperated with NPI team, and generated Control Plans using Process FMEA.

Initiated and led cost out projects for high-tech power products manufactured in multiple locations. Provided Six Sigma support for R&D projects and assisted in a $3M NPI from Poland technology side.

Led R&D projects in Design and Technology Centers in Poland and Belgium, coordinated cross-functional international teams in New Product Introduction, and prepared technical reviews.

Provided assembly line technical support and led several manufacturing projects, including plant consolidation.

Conducted supplier and internal audits, led incoming part approval team, established quality procedures, and implemented Supplier Quality Management System.

Responsible for quality aspects of line transfer and maintaining quality on assembly lines. Final inspection of finished goods and coordination of quality inspectors.

Provided technical support in producing automobile developments, established contacts with foreign suppliers, and handled homologation of special cars.

GMP Refresher training completed in 2025.

Postgraduate diploma in Public International Law and Diplomatic Services from the University of Warsaw, completed in 2020.

MDD course completed in 2018.

ISO9001:2015 requirements training completed in 2018.

ISO13485:2016 training completed in 2017.

Lead Auditor Pharmaceutical GMP certification completed in 2014.

Lead Auditor Certification for ISO14001 and ISO18001 completed in 2014.

IRCA Certification for Auditor schemes in Pharma GMP, QMS, EMS, and OHS, completed in 2014.

Lead Auditor Certification for ISO13485 completed in 2013.

Master Level Reiki Certification completed in 2011.

Lead Auditor Certification for ISO9001 completed in 2011.

Executive MBA from Athlone Institute of Technology, completed in 2011.

Impact business management training completed at Crotonville in 2005.

Technical training in Advanced Engineering, Reliability, NPI, and DFR completed in 2005.

Bachelor of Science in Mechanical Engineering with a specialty in Medical Appliances and Equipment, completed in 2001.

Secondary school graduation certificate with a mathematics-physics profile, completed in 1994.