Quality Systems Specialist – 1 | Japanese Bilingual
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Job Location:
Taguig - Philippines
Monthly Salary:
Not Disclosed
Posted on:
7 days ago
Vacancies:
1 Vacancy
Job Summary
At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
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.
Leads audit and inspection preparation resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders both internal and external.
Co-ordinates legal requests in support of government investigations or litigations.
Ensures the quality assurance programs and policies are maintained and modified regularly.
Facilitates uniform standards worldwide and enables best practice sharing thereby fostering the achievement of companys mission globally.
Details of the Actual Job Responsibilities.
Drafting and Translating an analysis results of complaint products (Analysis Letter) issued by the manufacturer from English to Japanese using appropriate vocabulary and phrasing suitable for Japanese into prescribed format. Drafting within two calendar days of receiving the Analysis Letter.
Sending the finalized letter to the sales representative after reviewing the draft by cross-functional team members in Japan.
Registering data relating with Analysis Letter into database systems (e.g. attaching emails or inputing data) and updating management lists in Excel and SharePointList.
Working with cross-functional team in Japan collaboratively.
There is an opportunity to take on stretch assignments.
Required Knowledge and Experience:
Requires broad theoretical job knowledge typically obtained through advanced education.
Requires a Baccalaureate degree (or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. 214.2(h)( 4)(iii)(A)
0 years of experience required.
Japanese Language Skill (JLPT: N3 N2 N1).
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.
Learn more about our business mission and our commitment to diversity here
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
