Sano Keigo (K5)
Premium
MAH Domestic QA Administr,
or / Manager, Quality Assurance / Japan QA Head, Intuitive Surgical
followers
3
following
0
Over 15 years experience in the Medical Device industry at Intuitive Surgical, Cook Medical, TÜV SÜD, and Johnson & Johnson.
・Over 11 years QMS / QA / QC Experience
・Almost 4 years R&D / New Product Development
My expertise is as follows.
・Regulations and International Standards for Medical Device (e.g. J-PMD Act, FDA QSR, European MDR, Canadian Medical Device Regulation, ISO 13485, ISO 14971, ISO 10993 series, ISO 11135 series and ISO 11137 series)
・Establishment, maintenance, and improvement of Quality Management System based on the regulatory requirements
・QMS submission for every product approval and for renewal
・License Control for MAH, Manufacturing/Oversea Manufacturing, Repair and Distribution
・Management of outsorcees, suppliers and subcontractors, including 3PL operation
・Regulatory submission document review (Shonin, Ninsho, and Todokede)
・Project Management including new product development and its launch
Experienced Products
・AQUA guidewire
・deja vu guidewire
・Precise and Angioguard(CAS system)
・Enterprise VRD
・Zenith AAA/TX2 Endovascular Graft
・Zilver PTX Drug-Eluting Peripheral Stent
・da Vinci S/Si/Xi/X Surgical System
・EndoWrist Instrument incl. Monopolar/Bipolar
・Advanced Instruments incl. Harmonic ACE, Vessel Sealer, Stapler and Suction Irrigator
・Accessories for da Vinci Surgical System incl. Simulator
Experienced Position
・MAH Domestic QA Administrator(第1種医療機器製造販売業 国内品質業務運営責任者)
・Deputy MAH Domestic QA Administrator(第1種医療機器製造販売業 国内品質業務運営責任者代行)
・Deputy Responsible Engineer(医療機器製造業 責任技術者代行)
・Notified Body & QM System Lead Auditor
・Document Assessor for Ninsho certification
・Over 11 years QMS / QA / QC Experience
・Almost 4 years R&D / New Product Development
My expertise is as follows.
・Regulations and International Standards for Medical Device (e.g. J-PMD Act, FDA QSR, European MDR, Canadian Medical Device Regulation, ISO 13485, ISO 14971, ISO 10993 series, ISO 11135 series and ISO 11137 series)
・Establishment, maintenance, and improvement of Quality Management System based on the regulatory requirements
・QMS submission for every product approval and for renewal
・License Control for MAH, Manufacturing/Oversea Manufacturing, Repair and Distribution
・Management of outsorcees, suppliers and subcontractors, including 3PL operation
・Regulatory submission document review (Shonin, Ninsho, and Todokede)
・Project Management including new product development and its launch
Experienced Products
・AQUA guidewire
・deja vu guidewire
・Precise and Angioguard(CAS system)
・Enterprise VRD
・Zenith AAA/TX2 Endovascular Graft
・Zilver PTX Drug-Eluting Peripheral Stent
・da Vinci S/Si/Xi/X Surgical System
・EndoWrist Instrument incl. Monopolar/Bipolar
・Advanced Instruments incl. Harmonic ACE, Vessel Sealer, Stapler and Suction Irrigator
・Accessories for da Vinci Surgical System incl. Simulator
Experienced Position
・MAH Domestic QA Administrator(第1種医療機器製造販売業 国内品質業務運営責任者)
・Deputy MAH Domestic QA Administrator(第1種医療機器製造販売業 国内品質業務運営責任者代行)
・Deputy Responsible Engineer(医療機器製造業 責任技術者代行)
・Notified Body & QM System Lead Auditor
・Document Assessor for Ninsho certification
MAH Domestic QA Administrator / Manager, Quality Assurance / Japan QA Head
August 2019 - present (4 years 8 months)
Quality Assurance, Post Market, Regulatory
Supervised the team members and compiled team budget as Japan QA Head.
Product Quality section
1. Managed product realization process and product change control process (i.e. new product introduction to Japanese market as well as product discontinuation).
2. Decided and approved product release and ship-hold for Japanese market as MAH Domestic QA Administrator.
3. Led the labeling manufacturer transfer project (3PL→3PL) and supported QMS establishment of the 3PL as project leader. Furthermore, led the project of product master, production management and label auto-printing IT system implementation via SAP as project leader.
4. Handled complaint from customer, and reviewed the returned product investigation results.
5. Managed field action (i.e. replacement and recall) as MAH Domestic QA Administrator.
6. Cooperated with Safety team to submit vigilance reporting to regulatory authority (i.e. PMDA).
7. Supported the work related to regulatory submission by RA team.
Quality Regulatory Compliance section
1. Established, maintained, improved, and controlled Quality Management System based on the requirements of J-PMD Act, relevant regulations and ISO 13485. Led the QMS establishment project team as project leader.
2. Coordinated QMS audit by regulatory authorities (i.e. PMDA, Prefectural and City Governments, Public Health Center and Registered Certification Body).
3. Controlled the licenses (i.e. MAH, Manufacturing/Oversea Manufacturing, Repair and Distribution licenses).
4. Participated in global projects. (e.g. International QMS harmonization, Correspondence of UDI, etc.)
5. Supported the work related to Healthcare Compliance.
Supervised the team members and compiled team budget as Japan QA Head.
Product Quality section
1. Managed product realization process and product change control process (i.e. new product introduction to Japanese market as well as product discontinuation).
2. Decided and approved product release and ship-hold for Japanese market as MAH Domestic QA Administrator.
3. Led the labeling manufacturer transfer project (3PL→3PL) and supported QMS establishment of the 3PL as project leader. Furthermore, led the project of product master, production management and label auto-printing IT system implementation via SAP as project leader.
4. Handled complaint from customer, and reviewed the returned product investigation results.
5. Managed field action (i.e. replacement and recall) as MAH Domestic QA Administrator.
6. Cooperated with Safety team to submit vigilance reporting to regulatory authority (i.e. PMDA).
7. Supported the work related to regulatory submission by RA team.
Quality Regulatory Compliance section
1. Established, maintained, improved, and controlled Quality Management System based on the requirements of J-PMD Act, relevant regulations and ISO 13485. Led the QMS establishment project team as project leader.
2. Coordinated QMS audit by regulatory authorities (i.e. PMDA, Prefectural and City Governments, Public Health Center and Registered Certification Body).
3. Controlled the licenses (i.e. MAH, Manufacturing/Oversea Manufacturing, Repair and Distribution licenses).
4. Participated in global projects. (e.g. International QMS harmonization, Correspondence of UDI, etc.)
5. Supported the work related to Healthcare Compliance.
MAH Domestic QA Administrator / Sr. Quality Assurance Specialist / Japan QA Lead
January 2018 - July 2019 (1 year 6 months)
Deputy MAH Domestic QA Administrator / Sr. Quality Assurance Specialist
May 2014 - December 2017 (3 years 7 months)
Deputy Responsible Engineer / Quality Systems Specialist
June 2012 - April 2014 (1 year 10 months)
Quality Systems, Quality Assurance and Safety Assurance
1. Established, maintained, improved, and controlled Quality Management System based on the requirements of J-PAL regulations and ISO 13485.
(e.g. Established, maintained and improved Quality Manual, Documented Procedures, Forms, and Device Master Records / Organized Management Review / Provided trainings related to J-PAL regulations and International Standards / Managed product realization process / Implemented and controlled validations including computer system validation / Managed and implemented internal/supplier audit including internal/supplier auditor training / Conducted Data Analysis / Managed and implemented CAPA)
2. Coordinated QMS audit by PMDA, Prefectural and City Governments and Notified Body.
3. Supported RA team, especially class II medical device certification.
4. Supported SCM/Labeling team as Deputy Responsible Engineer (Fuku-Sekinin-Gijutsu-Sha).
5. Participated in Global Projects (e.g. Document/Record Control, Risk Management, Computer System Validation, etc.).
6. Supported the work related to Healthcare Compliance.
7. Supervised and led the team members on behalf of Director of Quality/Safety.
1. Established, maintained, improved, and controlled Quality Management System based on the requirements of J-PAL regulations and ISO 13485.
(e.g. Established, maintained and improved Quality Manual, Documented Procedures, Forms, and Device Master Records / Organized Management Review / Provided trainings related to J-PAL regulations and International Standards / Managed product realization process / Implemented and controlled validations including computer system validation / Managed and implemented internal/supplier audit including internal/supplier auditor training / Conducted Data Analysis / Managed and implemented CAPA)
2. Coordinated QMS audit by PMDA, Prefectural and City Governments and Notified Body.
3. Supported RA team, especially class II medical device certification.
4. Supported SCM/Labeling team as Deputy Responsible Engineer (Fuku-Sekinin-Gijutsu-Sha).
5. Participated in Global Projects (e.g. Document/Record Control, Risk Management, Computer System Validation, etc.).
6. Supported the work related to Healthcare Compliance.
7. Supervised and led the team members on behalf of Director of Quality/Safety.
Notified Body & QM System Lead Auditor / Document Assessor for Ninsho certification
April 2009 - May 2012 (3 years 1 month)
Non-Active Medical Device Team, MHS Division
1. Provided audit service based on ISO 9001, ISO 13485, Medical Device Directive(93/42/EEC), Canadian Medical Device Regulation (CMDCAS) and MHLW Ministerial Ordinance No. 169, 2004(J-QMS). Furthermore, led the audit team as Notified Body & QM System Lead Auditor.
2. Assessed the documents regarding new Ninsho certification application, partial change application and minor change application as Document assessor under J-PAL.
1. Provided audit service based on ISO 9001, ISO 13485, Medical Device Directive(93/42/EEC), Canadian Medical Device Regulation (CMDCAS) and MHLW Ministerial Ordinance No. 169, 2004(J-QMS). Furthermore, led the audit team as Notified Body & QM System Lead Auditor.
2. Assessed the documents regarding new Ninsho certification application, partial change application and minor change application as Document assessor under J-PAL.
New Product Development Engineer
April 2005 - December 2008 (3 years 8 months)
Advanced Product Development Team, Science & Technology
1. Led the NPD project teams organized from the departments of Marketing, Quality Assurance, Regulatory Affairs, Clinical, Vigilance/Safety, Manufacturing and SCM as NPD Engineer and Project Manager. Designed and developed medical devices for IVR (e.g. Guidewire used for CTO of lower limb vascular and for Neurovascular).
2. Implemented technical research and product development of new medical devices (e.g. Atherectomy device, Bioabsorbable Stent, and Regenerative Medicine).
3. Established, maintained and improved SOPs based on ISO 13485 and ISO 14971.
4. Provided technical support to Doctors and Sales (e.g. Carotid Stent and Embolic protection device)
1. Led the NPD project teams organized from the departments of Marketing, Quality Assurance, Regulatory Affairs, Clinical, Vigilance/Safety, Manufacturing and SCM as NPD Engineer and Project Manager. Designed and developed medical devices for IVR (e.g. Guidewire used for CTO of lower limb vascular and for Neurovascular).
2. Implemented technical research and product development of new medical devices (e.g. Atherectomy device, Bioabsorbable Stent, and Regenerative Medicine).
3. Established, maintained and improved SOPs based on ISO 13485 and ISO 14971.
4. Provided technical support to Doctors and Sales (e.g. Carotid Stent and Embolic protection device)
Tokyo Institute of Technology
Master of Engineering
Genetic engineering / Fermentation engineering for Microbiological Technology
2003 - 2005
Tokyo University of Science
Bachelor of Science
Applied Chemistry
1999 - 2003
Instructor of The Fair Competition Code of the Medical Devices Industry in Japan
The Fair Trade Committee of the Medical Devices Industry in Japan
Issued on July 2012 - Expire on June 2022
Lead Auditor for MHLW Ministerial Ordinance No. 169, 2004
MHLW / TÜV SÜD Japan Ltd.
Issued on December 2010 - Doesn't expire
Document Assessor for Ninsho certification under J-PAL
MHLW / TÜV SÜD Japan Ltd.
Issued on December 2010 - Doesn't expire
Lead Auditor (ISO 9001)
TÜV SÜD Management Service GmbH
Issued on June 2010 - Doesn't expire
Notified Body & QM System Lead Auditor (ISO 13485)
ZLG / TÜV SÜD Product Service GmbH
Issued on May 2010 - Doesn't expire
Notified Body & QM Syetem Auditor (ISO 13485)
ZLG / TÜV SÜD Product Service GmbH
Issued on August 2009 - Doesn't expire
Auditor (ISO 9001)
TÜV SÜD Management Service GmbH
Issued on August 2009 - Doesn't expire
Similar members
Goodyear Tire and Rubber Company - Senior Automotive Expert / Tokyo,
Japan
President,
Abbott Medical Japan
Senior Sales Manager,
Baldwin Japan Ltd
Head of Governance & Compliance,
Allianz Life Insurance Japan Ltd.
Technology Consultant,
Accenture Japan
Oper,
ions Manager, Financial Planning & Analysis, Guthy-Renker Japan