Job Description
Careers That Change Lives
As Quality Systems Specialist you will have responsibility for development of and maintenance of quality programs including training and documentation. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
GMP (Good Manufacturing Practice) operations including follows
Well organized and planned execution skill is needed to complete the GMP on time
Actively work with GMP stakeholders
High analyze skill is required to detect the risk on time
Understanding the time manner for processing GMP
English and Korean speaking and writing skill is very essential
High performance of collaboration with Korea GMP team
General Regulatory Affairs requirements
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Monitors and improves tracking / control systems.
General Quality Management System operations including follows
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Must Have
Bachelor's Degree Required in Medical/ biological science/ Engineering or equivalent field
0 years of experience required
Korean communication skills (Business Level)
Your Profile
Stakeholder relationship management
Strong communication and interpersonal skills
Strong ability to work well within a team and autonomously
Achievement oriented and ability to drive results with the highest quality standards
Computer skills (excellent knowledge of MS Office, Excel, computer systems).
High attention to detail and accuracy.
Good prioritization and organizational skills, as well as problem-solving skills
Good command of English language both verbal and written.
Self-starter, shows initiative and has a can do mentality
Strong passion for quality and continuous improvement processes
Agile and adaptable to rapidly changing needs of the business and environment
With 1 to 3 years of relevant experience as Quality System Specialist role (QMS, Change Control & Document Control) or QA Role
Careers That Change Lives
As Quality Systems Specialist you will have responsibility for development of and maintenance of quality programs including training and documentation. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
GMP (Good Manufacturing Practice) operations including follows
Well organized and planned execution skill is needed to complete the GMP on time
Actively work with GMP stakeholders
High analyze skill is required to detect the risk on time
Understanding the time manner for processing GMP
English and Korean speaking and writing skill is very essential
High performance of collaboration with Korea GMP team
General Regulatory Affairs requirements
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
Leads or compiles all materials required in submissions, license renewal and annual registrations.
Monitors and improves tracking / control systems.
General Quality Management System operations including follows
Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
Must Have
Bachelor's Degree Required in Medical/ biological science/ Engineering or equivalent field
0 years of experience required
Korean communication skills (Business Level)
Your Profile
Stakeholder relationship management
Strong communication and interpersonal skills
Strong ability to work well within a team and autonomously
Achievement oriented and ability to drive results with the highest quality standards
Computer skills (excellent knowledge of MS Office, Excel, computer systems).
High attention to detail and accuracy.
Good prioritization and organizational skills, as well as problem-solving skills
Good command of English language both verbal and written.
Self-starter, shows initiative and has a can do mentality
Strong passion for quality and continuous improvement processes
Agile and adaptable to rapidly changing needs of the business and environment
With 1 to 3 years of relevant experience as Quality System Specialist role (QMS, Change Control & Document Control) or QA Role
Submit profile
Medtronic Cardiac and Vascular
About the company
Medtronic Cardiac and Vascular jobs
Taguig ,
Position Associate quality systems specialist - korean speaker recruited by the company Medtronic Cardiac and Vascular at Taguig, Joboko automatically collects the salary of , finds more jobs on Associate Quality Systems Specialist - Korean Speaker or Medtronic Cardiac and Vascular company in the links above
About the company
Medtronic Cardiac and Vascular jobs
Taguig ,