
Quality Systems Specialist
4 days ago
**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.
**A Day In The Life
**As a Quality System Specialist, you will have the responsibility of collaborating with cross functional teams to review, manage, and promote changes that meet the product requirements, company branding guidelines and global standards.
- 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 company's mission globally.
**Must Haves**:
- Bachelor’s degree required Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
**Your Profile**:
- Knowledge of Quality Management System principles, and experience working within a certified Quality System (ISO 9001, ISO 13485 or similar) will be highly regarded.
- Experience in project management and coordination
- Good communication and interpersonal skills, ability to articulate ideas clearly and concisely to people of all levels. Computer literacy including sound knowledge of the MS Office, MS Word & Excel & PowerPoint
**About Medtronic Singapore Operations
**Medtronic Singapore Operations was among the first international medical technology firms to set up manufacturing operations in Singapore. We are one of the most advanced medical device manufacturing sites and the first manufacturing facility of its kind in the region to make implantable cardiac leads, pacemakers and monitors.
As a company Medtronic is intensely focused on creating a workplace environment which reflects our standing as the world’s top medical device company.
**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 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. The physical demands described within the Day in the Life 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.
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