Quality Systems Specialist
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Job Location:
Petaling Jaya - Malaysia
Monthly Salary:
Not Disclosed
Posted on:
22 hours 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
The Quality Systems Specialist is responsible for supporting and strengthening Medtronics Quality Management System (QMS) to ensure compliance with internal policies and applicable regulatory and governmental requirements. This role partners closely with site and regional stakeholders to oversee quality processes support audits and inspections and drive continuous improvement initiatives. The specialist applies practical quality and regulatory knowledge to maintain effective quality programs while enabling best practice sharing and global alignment across the organization.This position operates with a high degree of independence on moderately complex projects and plays a key role in ensuring Medtronic Malaysia continues to meet global quality and compliance expectations.
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:
Bachelors Degree in Engineering Science Quality or a related discipline.
Minimum of two years of relevant quality regulatory or compliance experience
Practical working knowledge of quality systems and quality assurance principles.
Familiarity with regulatory and industry standards applicable to medical devices (e.g. ISO 13485 MDSAP or equivalent).
Experience supporting audits and inspections including preparation and response activities.
Ability to interpret regulations policies and procedures and translate them into actionable guidance for stakeholders.
Strong documentation and report-writing skills including experience with CAPA or similar quality tools.
Ability to work independently with general supervision on moderately complex assignments.
Effective communication skills with the ability to collaborate across functions and share information clearly and professionally.
Experience working in a regulated medical device or healthcare manufacturing environment.
Exposure to global or regional quality systems
Experience supporting continuous improvement or process optimization initiatives.
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
