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Senior Quality Systems Specialist
2 semanas atrás
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**:The position offers a dynamic opportunity to lead and evolve a global audit program and the QMS (Quality Management System) process within the healthcare industry, ensuring compliance with ISO 13485 and GxP (Good Practices) standards. The responsibilities of the position include managing audits, training teams, overseeing QMS (Quality Management System) projects, monitoring key quality metrics, and implementing automation to streamline processes.
**Responsibilities may include the following and other duties may be assigned**:
- Support and document KPIs for monthly audit change control, and QMS (Quality Management System) objectives while providing mitigation, correction, and improvement plans for unmet KPI targets
- Collaborate with operating groups and the Enterprise team to provide guidance, knowledge, and oversight of all activities within audit, change control, and QMS (Quality Management System) processes, while analysing and executing projects alongside stakeholders
- Coordinate cross-functional teams to ensure successful project execution
- Offer guidance and expertise in interpreting policies, regulations, and procedures to ensure compliance
- Support the process of self-inspections, internal and external audits and participate in the resolution of the findings to the applicable QMS ( Quality Management System)
- Lead and participate in projects within the audit, change control, and QMS (Quality Management System) processes and automation
- Ensure all related activities are updated and meet QMS (Quality Management System) requirements when managing documents or processes
**Required Knowledge and Experience**:
- Bachelor’s degree in Life Science, Engineering, or a related degree, such as Pharmacy or Biomedical Engineering
- At least 4 years of experience in a quality role within the healthcare industry, with a strong emphasis on ISO 13485 and/or GxP (Good Practices) requirements, such as Good Distribution Practice (GDP) or Good Manufacturing Practices (GMP)
- Fluent in English and Spanish
- Project management skills
- Lead or Internal Auditor certification in QMS (Quality Management System), such as ISO 13485 or GMP (Good Manufacturing Practices)
Additional nice to haves are experience with Python, Power Automate, and Power BI, as well as a strong understanding of Medical Device Regulations and the Food and Drugs Acts relevant to the position.
**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 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.
