Quality Systems Specialist - Japanese Bilingual
Careers that Change Lives
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.
As Quality Systems Specialist you will have responsibility for development of and maintenance of quality programs focusing on Document Control for managing Documents and Records in accordance with Quality Management System and Local Japanese Standards.
A Day in the Life
- Provide oversight for the implementation of Quality Management System Processes, focusing on Document Control for Japanese Quality System Documents and Records in the form of a centralized shared service provision, in compliance with internal and external guidelines
- Work with Subject Matter Experts based in Japan to ensure Document Control process is effectively implemented and maintained.
- Works directly with operating entities to provide regular and consistent process analysis oversight to enforce requirements and meet regulations.
- Support audit and inspection preparation, including the resolution of audit and inspection findings, and collaborate with auditing groups and inspectors through all stages of the audits.
- Prepare reports and necessary documentation for internal and external stakeholders
- Actively communicate and collaborate with Process Owners, Managers, Learners, and Employees within the organization
- Analyze data to identify trends and opportunities for improvement on quality aspects, and Support process improvement projects.
Must Have: Minimum Requirements:
- Bachelor’s Degree is required
- Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Your Profile
- 1 – 2 years of relevant Quality Management Systems Process experience, such as Corrective and Preventive Action, Supplier Management, Audit, Manage Compliance
- Bilingual proficiency in English and Business Level Japanese Language (N2 JLPT level or higher)
- Knowledgeable in ISO and standards (9001:2015 and/or 13485:2016)
- Knowledgeable in Project Management or Improvement Initiatives (Lean, Six Sigma, Kaizen
- Hands-on knowledge on Microsoft Office systems, including Microsoft Excel
- Strong stakeholder relationship management and communication skills
About Medtronic Philippines
Established in 2015, Medtronic Philippines is committed to best-in-class patient and customer experience by delivering capacity, scalability, sustainable productivity levels and innovative solutions to our stakeholders, patients and customers.
The establishment has over 450 employees on-site with more than 60% being female employees
What We Offer
We recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success. We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage. As a result, our employees have access to the following benefits, to name a few:
- Our global well-being program supports your physical, emotional, social and financial well-being.
- Medtronic Employee Assistance Program offers confidential support and resources to build and enhance employee and organizational resilience, productivity, teamwork and psychologically healthy workplaces.
- Various insurance benefits include Inpatient and Outpatient Medical Insurance, Life, Disability and Accident Insurance.
- We have generous employee referral programs, employees stock purchase plan, leave benefits, and more!
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
