QcRM, Quality Assurance Manager

At Getinge we have the passion to perform

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

Are you looking for an inspiring career? You just found it.

Job Purpose:

In collaboration with the QRC Director, the Quality Assurance Manager is responsible to manage and drive the daily activities in Quality Assurance (QA) Quality Control (QC) and -Engineering (QE). The position leads the site QA, QC and QE teams and acts as the 国内品質管理業務運営責任者(Quality Assurance Manager defined by PMD Act). He/She supports the QRC Director during internal and external audits and inspections.

• Head of Quality Assurance at a manufacturer and distributor
• Oversee domestic quality control operations.
• Confirming that domestic quality control operations are being carried out properly and smoothly.

Functions:

• Quality Assurance of the Medical Devices
• 国内品質管理業務運営責任者
   

Key duties and responsibilities:

• Develop and manage staffing plans in the organization
• To manage the decision-making process following the rules of authority.
• Internal and external audits
• SOP creation and management
• Education and Training Planning and Implementation Management
• Continuous Improvement Lead Management
• Change management, evaluation, and monitoring and guidance
• Process monitoring and management
• Risk Management
• Quality target setting and management
• Management Review
• Cost Management
• Org Management / HRM
  • Develop and manage staffing plans in the organization
  • To manage the decision-making process following the rules of authority.
  • Responsible for developing the talent of team members.
  • Manage the JD of a team member.
  • Manage team member performance through PDP
  • Evaluate team members' abilities and develop and manage the implementation of necessary training plans if there are gaps in JD

Quality System Duties and Responsibilities:

• Supervise domestic quality control operations + 3PL Quality Control Operation Guidance
• Confirming that domestic quality control operations are being carried out properly and smoothly.
• Head of Quality Assurance at a manufacturer and distributor
• Management of medical device shipping decisions
• Manufacturer monitoring and guidance
• Quality Agreement Management
• Support Post Market Surveillance and Adverse event handling
• Complaint Handling Process Management
• Ensuring consistency with the global QMS
• KAIZEN
  • KAIZEN project management
  • Surpport KAIZEN of other departments
•     Product Quality Management
  • Local Design Review for new products introduction
  • Quality Information Control
  • Safety Corrective Action (Physical)
  • Medical Device Change Management
  • Product Master Files maintenance
  • Control of product release to the market
  • Support new product introduction into Japanese market after product registration by Regulatory Affairs
• Confirmation of progress in QMS compliance survey applications
  • Confirmation of Certificate of Compliance deadlines and management of operations for receipt of Certificates of Compliance within the deadlines through bi-weekly quality assurance department meetings
  • Certificate of Compliance Due Date Progress Management Table, double-checking status and record management

Knowledge/Skills/Experience:

• Must qualify with the requirements of “Quality Assurance Manager” or “Responsible Engineering Supervisor” in accordance with PMD Act, MHLW Ministerial Ordinance
• Bachelor or Master in science, medical, engineering or similar or extensive experience in medical device manufacturing
• Document management, report writing
• Good knowledge of the English language
• Knowledge in SAP, especially the QM module is a plus
• Personal qualities:
• Quality Assurance, Statistical Methods, Six Sigma, Risk Management experiences are a plus.
• Very good proven statistical knowledge
• Quality Mgmt standards (ISO 13485, QSR, PMD Act, etc.) / TQM

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.