30.09.2026 aktualisiert
40 % teilweise verfügbar
Chief Quality Officer | Medical Devices | QMS | Regulatory Affairs
Cottbus, Deutschland
Nur Remote
M.Sc. Polymer TechnologyÜber mich
Over 11 years of experience and leadership in life sciences industry. I bring a track record of defining and executing quality and regulatory strategies for medical devices (incl. IVD, Software). I support addressing problems with innovative solutions and providing evidence-based insights.
Skills
(American Society for Quality) ASQ CertifiedQualitätsauditQualitätsmanagementMedizinproduktenCertified Quality ManagerRegulatory ChangeQualitätskontrolle
Quality Management Systems (QMS)
Expertise in development, implementation, and maintenance of QMS compliant with ISO 13485, FDA 21 CFR Part 820, EU MDR, and global medical device regulatory standards, including CAPA, change control, non-conformance, complaint handling, risk management, design controls, process validation, and equipment qualification.
Regulatory Affairs & Compliance
Deep knowledge of EU MDR, IVDR, FDA 21 CFR, MDSAP, ISO 42001, EU AI Act, and ISO 27001. Proven track record in preparing regulatory pathways and technical documentation for EU, MDSAP, ASEAN, GCC, and India submissions, as well as leading MDR transition programs and UDI/EUDAMED compliance projects.
Auditing & Supplier Quality
Certified CQI/IRCA Lead Auditor for ISO 13485:2016 and ISO 27001:2022 with over 200 audit days. Extensive experience in planning, conducting, and documenting supplier quality audits, management system auditing per ISO 19011, and supporting WHO as Co-Inspector for IVD prequalification activities.
Statistical Process Control (SPC)
Application of Statistical Process Control methods and Design of Experiments (DOE) using tools such as Minitab v17 to support R&D teams in planning verification and validation activities and optimizing manufacturing processes.
Risk Management (ISO 14971)
Creation and maintenance of risk management files in accordance with ISO 14971, covering medical devices including SaMD, SiMD, IVDs, and digital health technologies across multiple regulatory jurisdictions.
Change Management & Design Controls
Coaching of companies in implementation of design controls and change management processes. Leadership of QMS merging activities in the context of M&A at global companies.
CSV & Manufacturing Process Validation
Leadership of computer system validation (CSV) and manufacturing process validation, including additive manufacturing, at multiple companies. Creation and revision of SOPs, work instructions, and validation plans (IQ, OQ, PQ).
Six Sigma & Lean Management
Certified Six Sigma Green Belt with experience in applying Lean principles for process optimization and waste elimination, as well as root cause analysis methods such as Fish Bone, 8D, and 5Why.
Digital Health & AI/ML Compliance
Support of medical device and digital health manufacturers across SaMD, SiMD, AI/ML, cybersecurity, software lifecycle management, and interoperability, including training on EUDAMED, MDSAP, and AI/ML compliance requirements.
Project Management
Management of multiple supplier and part qualification projects simultaneously, including project planning, risk assessment, stakeholder coordination, progress tracking, and cross-functional communication to support operational efficiency.
Expertise in development, implementation, and maintenance of QMS compliant with ISO 13485, FDA 21 CFR Part 820, EU MDR, and global medical device regulatory standards, including CAPA, change control, non-conformance, complaint handling, risk management, design controls, process validation, and equipment qualification.
Regulatory Affairs & Compliance
Deep knowledge of EU MDR, IVDR, FDA 21 CFR, MDSAP, ISO 42001, EU AI Act, and ISO 27001. Proven track record in preparing regulatory pathways and technical documentation for EU, MDSAP, ASEAN, GCC, and India submissions, as well as leading MDR transition programs and UDI/EUDAMED compliance projects.
Auditing & Supplier Quality
Certified CQI/IRCA Lead Auditor for ISO 13485:2016 and ISO 27001:2022 with over 200 audit days. Extensive experience in planning, conducting, and documenting supplier quality audits, management system auditing per ISO 19011, and supporting WHO as Co-Inspector for IVD prequalification activities.
Statistical Process Control (SPC)
Application of Statistical Process Control methods and Design of Experiments (DOE) using tools such as Minitab v17 to support R&D teams in planning verification and validation activities and optimizing manufacturing processes.
Risk Management (ISO 14971)
Creation and maintenance of risk management files in accordance with ISO 14971, covering medical devices including SaMD, SiMD, IVDs, and digital health technologies across multiple regulatory jurisdictions.
Change Management & Design Controls
Coaching of companies in implementation of design controls and change management processes. Leadership of QMS merging activities in the context of M&A at global companies.
CSV & Manufacturing Process Validation
Leadership of computer system validation (CSV) and manufacturing process validation, including additive manufacturing, at multiple companies. Creation and revision of SOPs, work instructions, and validation plans (IQ, OQ, PQ).
Six Sigma & Lean Management
Certified Six Sigma Green Belt with experience in applying Lean principles for process optimization and waste elimination, as well as root cause analysis methods such as Fish Bone, 8D, and 5Why.
Digital Health & AI/ML Compliance
Support of medical device and digital health manufacturers across SaMD, SiMD, AI/ML, cybersecurity, software lifecycle management, and interoperability, including training on EUDAMED, MDSAP, and AI/ML compliance requirements.
Project Management
Management of multiple supplier and part qualification projects simultaneously, including project planning, risk assessment, stakeholder coordination, progress tracking, and cross-functional communication to support operational efficiency.
Erfahrung
Berufserfahrungmehr als 10 Jahre
Freelancer seit2025
Sprachen
DeutschgutEnglischverhandlungssicherHindiMutterspracheTeluguMuttersprache
Projekthistorie
Led development and implementation of a company-wide QMS compliant with ISO 13485, FDA 21 CFR Part 820, EU MDR, and global medical device regulatory standards. Directed quality and regulatory strategy across product development, manufacturing, and commercialization. Supported development and growth of high-performing teams through hiring, mentoring, and leadership development. Managed supplier quality programs, quality metrics, KPI dashboards, departmental budgets, and resource allocation. Provided strategic leadership and communication to executive leadership, board members, investors, and external stakeholders on quality performance and compliance risks.
Consulted with medical technology clients to develop and implement quality and regulatory strategies aligned with FDA, ISO 13485, EU MDR, and global medical device compliance requirements. Led and executed quality and regulatory initiatives including QMS development, audit readiness, risk management, design controls, CAPA systems, supplier quality, and process validation activities. Partnered with cross-functional client teams to support product development, commercialization, operational improvement, and regulatory compliance objectives in startup and growth-stage environments.
Supported a global medical device manufacturer in supplier qualification, part qualification, and quality assurance activities for medical device components and products. Served as Lead Auditor for supplier qualification and compliance assessments. Planned, conducted, and documented supplier quality audits, including issuance of audit reports, identification of non-conformities, and follow-up on corrective and preventive actions. Managed multiple supplier and part qualification projects simultaneously.
Zertifikate
Lead Auditor ISO 13485:2016
Tüv Süd2025
Lead Auditor ISO 27001:2022
Tüv Süd2025
RAC - Device
Regulatory Affairs Professional Society (RAPS)2022
Certified Medical Device Auditor
American Society of Quality (ASQ)2021