Quality Systems Specialist
Share
Job Location:
Taguig - Philippines
Monthly Salary:
Not Disclosed
Posted on:
16 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
This position is an exciting opportunity to work with Medtronics Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential enabling us to operate with greater speed and agility. As a separate entity we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care.Responsibilities may include the following and other duties may be assigned:
Supports 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.
Conduct quality reviews of Change Orders for Quality Management System documents and records.
Provides expertise and guidance to stakeholders in interpreting policies regulatory and/or governmental regulations and internal regulations to assure compliance.
Supports 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 data analysis etc. and provides to applicable stakeholders.
Co-ordinates implementation of enterprise changes within local quality management system.
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.
Leads smaller quality projects and project teams while facilitating larger quality projects in a variety of roles
Required Knowledge and Experience:
Bachelors Degree in Pharmaceutical Sciences Industrial Engineering Biomedical Engineeringor field related experience
Experience with medical device industry Regulations Standards and Quality Management Systems
Intermediate or better level of experience with Microsoft suite including but not limited to Word Excel SharePoint Teams PowerPoint and Adobe
Experience with Oracle Agile Trackwise and/or PowerBI systems
Experience in FDA Certifying Body and/or Notified Body audits/inspections
Experience or training in project management
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
