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Senior Quality Systems Specialist

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Descripción del trabajo - Senior Quality Systems Specialist

At MiniMed, you can begin a lifelong career of exploration and innovation, while helping make a difference in the lives of people living with diabetes around the globe. You'll lead with purpose, breaking down barriers to innovation for a more connected, compassionate world.

About the Role

We are looking for an experienced quality specialist with proven experience and decision-making authority in Quality and regulatory responsibilities.  

Responsibilities may include the following and other duties may be assigned: 

  • Accountable for the management of the Quality Management system for their assigned country/geography.  

  • 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 and deliver a direct business impact. 

  • Works directly with commercial, various functions and operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. 

  • Leads audit and inspection readiness and acts as primary interface with regulatory authorities and trade bodies. 

  • Owns the resolution of audit/inspection findings and CAPAs. 

  • 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. 

What makes this role unique: 

  • Autonomy & Ownership: Lead your work independently and shape your approach to solving complex problems. Coach and guide junior colleagues while managing key projects. 

  • Organizational Impact: Take full responsibility for projects or processes, driving team objectives and building consensus across stakeholders. 

  • Innovation & Complexity: Tackle challenging issues that span multiple areas. Improve processes, systems, and products, providing in-depth analysis and actionable recommendations. 

  • Communication & Influence: Collaborate with senior internal and external partners, sharing ideas and insights to drive decisions and achieve results. 

  • Leadership & Talent Development: Mentor, coach, and train colleagues. Lead projects with delegation and oversight to ensure high-quality outcomes. May provide guidance to other employees within job area. 

Required Knowledge and Experience:  

  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. 

  • May have practical knowledge of project management. 

  • Requires a bachelor’s degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience. 

#BetterDaysStartNow

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

MiniMed offers a competitive salary and flexible benefits package

At MiniMed, we put people first. A commitment to our employees lives at the core of our values: We recognize their contributions. They share in the success they help create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every stage of your career and life.


 

About MiniMed

We want to make every day a better day for people living with diabetes. Our team of creative innovators around the globe share a passion for finding the simplest solutions to the problems that people with diabetes face on a daily basis. For more than 40 years, we've been redefining what's possible, from intelligent dosing systems designed for real life to predictive insights that stay a step ahead, and we're dedicated to continuing to support our customers through every step of their journey — meeting them where and how they need it.

Original job Senior Quality Systems Specialist posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs.
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