Quality Management System Specialist
Quality Management System Specialist
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Job Description
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
JOB TITLESenior QUALITY SYSTEMSL SPECIALIST
DEPARTMENT QMS / QUALITY MANAGEMENT
REPORTING TO SENIOR QUALITY SYSTEMS MANAGER
MAIN PURPOSE OF JOB:
- Improve and maintain the effectiveness and efficiency of quality management systems and conformance to regulatory requirements of medical devices while considering the needs of customers.
MAIN JOB DUTIES / RESPONSIBILITIES:
- Establishment and maintenance of quality management systems focusing on QMS governance and management of QMS requirements
: FocusQMSManagement ReviewQMS
- Management of projects for improving QMS
Careers That Change Lives
Quality Management System is the function that establishes and maintains the processes affecting product quality and patient safety based on reguratory requirements such as Japan PMD Act. MHLW Ordinance #169 (QMS Ordinance) ISO13485 and so on. The function is the basis of the business of medical devices business enabler. The position will be responsible for:
- CAPA (corrective actions and preventive actions): The provcess to take actions to eliminate the causes of nonconformities which are identifiled through the use of various processes such as audits post-market surveillance analysis of the data and so on in order to prevent recurrence.
- Internal Audit: Plan and conduct internal audit to determine whether the quality management system conforms to the regulatory requirements and the procedures and is implemented effectively.
- Business licence management: Gain and renew business licenses which are required to do the business of medical devices in Japan
QMSISO13485
- CAPA
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.
Required Knowledge and Experience:
Requires mastery of a specialty area and full knowledge of industry practices typically
obtained through advanced education combined with experience. May have broad knowledge of project management. Requiresa 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) and minimum 7 years of relevant experience or advanced degree with a minimum of 5 years of relevant experience.
. 75
Nice to Have
- Practical knowledge on executions of quality-reated processes and safety controls
- Fluent in English Presentation skills in English and communications skills in the meeting are preferred.
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:
Unclear Seniority
Employment Type
Full-Time
