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Quality Assurance Manager / Senior Manager Japan

Role
Quality Assurance
Location

Tokyo

Japan
Job Description

The main purpose of this role is to implement and maintain Quality Systems, Quality Assurance requirements and processes in accordance with Japan Pharmaceuticals and Medical Device Act, ISO 13485 and other applicable regulatory requirements.

 

The incumbent acts as a quality management representative for the Hoya Corporation Medical division, and will be assigned as domestic quality assurance manager per PMDA regulations.

 

Key duties and responsibilities:

  • Collect and learn up-to-date Japanese regulatory requirements to share with stakeholders to ensure ongoing compliance
  • Implement and maintain effective quality system for HOYA Corporation and Medical Division to ensure that local operations are fully compliant with Hoya Surgical Optics (HSO) Global requirements, SOPS, standards and policies, GMP, ISO, and regulatory requirements by law
  • Promote high quality standards by participating as a member of the management team to influence/coordinate all quality related activities, and where necessary, develop and implement local quality policies and procedures
  • Provide technical information and support to external contacts such as local authorities, customers, suppliers, and distributors
  • Maintain regular contacts with the HSO factories, R&D, Regulatory Affairs, and Quality teams to discuss, resolve quality and technical issues
  • Ensure that products in Japan are stored and distributed under appropriate conditions so that they reach their intended destination intact and without detrimental impact on their quality i.e. environmental factors or malicious acts
  • Control Manufacturing and Distribution/sales licenses in cooperation with the Regulatory Affairs department
  • Host and manage Japan consolidated management review
  • Control and manage suppliers
  • Act as a Host for all external audits (SGS, TUV, PMDA etc)
  • Own and manage the budget of QA team in Japan
  • Complete any other assigned duties as required

 

This role has duties and responsibilities for Japan HSO organization (HOYA Corporation Medical division and HOYA Medical Logistic Center (HMLC), Japan Sales selected processes) as follows;

 

1. Maintenance of Management of Quality System

  • Quality Policy/Quality Objectives/Quality Indicator
  • Establish Quality Documents
  • Manage the CAPA System and ensure compliance
  • Internal Audit management (planning, executing)
  • Management Review Preparation
  • Document Control

 

2. Quality Assurance Supervisor in accordance with Japan PMD-Act

  • Implement recall/s as necessary as per Global HSO processes
  • Control of shipments, manage NC and escalate as required
  • Review shipping approval (HMLC & consigned company)
  • Authority and responsible to decide on products hold and release

 

3. Responsible Engineer (or back up) in accordance with Japan PMD-Act

  • Decide shipping approval for imported products

 

4. Maintenance of QMS Certificate

  • ISO13485: SGS for HMLC & HOYA Corporation
  • Japan QMS No. 169

 

5. Control of Subcontractor

  • Periodic meetings with contract manufacturers and other suppliers
  • External Audits (including audits by qualified organization outside HOYA, such as Notified Bodies, TUV, SGS, or Authorities such as PMDA), consigned companies, and HOYA group companies/branches

 

6. Improvement of Product Quality

  • IOL improvement initiatives
  • Other ophthalmic device

- HHV series

- Speculum

- Micro Forceps

- Other new devices in the future etc.

 

Education

  • Bachelor’s Degree or above in a science/technical field

 

Experience

  • At least 5 to 7 years in the management of Quality, Regulatory Affairs or related functions with extensive experience in Medical Devices requirements in Japan
  • Risk Management based on ISO 14971

 

Skills

  • Leadership, staffing, and people skills
  • Project management skills (both written and oral), budgeting and analytical skills that demonstrate the ability to recognize when system or staff adjustments are needed.
  • Good communication and negotiation skills (internally – within the team, between departments and regions (International, SBU, Global, etc.), and externally – PMDA , Notified Body, MHLW, TMG, etc.)
  • Knowledge of manufacturing processes of medical devices
  • Proficient in process mapping, flowcharting, database systems, Excel spreadsheet, Microsoft Office, and automated quality systems
  • Proficient and fluent in English, with the ability to write to and communicate with functions outside of Japan

 

Travel requirements

  • International and Domestic business travel may be required

 

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes. For more information about the processing of your personal data, please refer to our Privacy Policy, which can be found here.

 

We regret to inform you that only shortlisted applicants will be notified. Thank you for your kind understanding.

 

 

Apply Now or E-Mail your resume to hso-ghq-hr@hoya.com; subject “Application for 'Job Title'”. Thank you!