Sr Quality Systems Spec

Reposted Yesterday
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Ho Chi Minh City, Ho Chi Minh
In-Office
Senior level
Healthtech
The Role
The role oversees quality programs in compliance with regulations, leads audits, coordinates legal requests, and maintains quality assurance systems.
Summary Generated by Built In

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

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 company's mission globally.

Required Knowledge and Experience:

  • Requires a bachelor’s degree, preferably in Engineering, Biomedical, or other relevant technical fields

  • Least 4+ years of practical experience in Quality Management within the medical device industry

  • Strong understanding of quality and regulatory system requirements such as ISO 13485 or GMP is essential

  • Possessing an ISO 13485 Lead Auditor certification is a strong advantage

  • Demonstrated ability to apply practical knowledge and sound judgment to effectively manage and improve quality processes.

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.
 

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).

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 95,000+ 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  
 

Top Skills

Gmp
Iso 13485
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The Company
HQ: Minneapolis, MN
80,303 Employees

What We Do

Medtronic is a global healthcare solutions company operating in approximately 160 countries. We are committed to improving lives through our medical technologies, services, and solutions.

Since our beginning, 60 years ago, our Mission has remained the same: to alleviate pain, restore health, and extend life for people around the world. The Mission is our ethical framework and inspirational goal guiding our day-to-day work. It reminds us that our efforts are transforming millions of lives each year.

To meet the needs of patients and healthcare professionals around the globe, we operate from more than 370 locations in approximately 160 countries.

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