Quality Systems Spec
hace 4 semanas
**Careers that Change Lives**
A career at Medtronic is like no other. We’re committed to and driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide
We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.
Join a diverse team of innovators who bring their worldview, their unique backgrounds and their individual life experiences to work every day. It’s no accident - we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions.
To learn more about Inclusion & Diversity at Medtronic Click Here
**A Day in the Life**
- As Quality Systems Specialist you will have responsibility for development of and maintenance of quality programs including Document Control, Corrective and Preventive Action, Supplier & Distributor Management, and Manage Compliance.
- 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.
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.
- Responsibilities may include the following and other duties may be assigned.
- Provide oversight for the implementation and development of Quality Management Systems Processes to support Medtronic’s Global.
- Region in the form of centralized shared service provision.
- Ensure compliance with policies and that the performance of Quality Services conform to established internal/external standard and guidelines.
- Work with Subject Matter Expert across globe to ensure Quality Management Systems Processes (Document Control, Corrective and Preventive
- Action, Supplier and distributor Management, and Compliance) are effectively implemented in the Global Region.
- Works directly with operating entities to provide process analysis oversight on a continuing basis to enforce requirements and meet regulations.
- Support 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 and provides to applicable stakeholders, both internal and external.
- 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 the company's mission globally.
- Actively communicate and collaborate with process owners, learners, managers and other employees within the organization.
- 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.
- Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
**Must Have: Minimum Requirements**
- Bachelor's degree required, preferably in Engineering, Quality or equivalent.
- Minimum of 2+ years of relevant experience (Quality System Specialist role or must be knowledgeable with QMS Processes (Document Control, Corrective and Preventive Action, Supplier & Distributor Management, Manage Compliance), or advanced degree (Master) with 1+ years of experience.
- Good communication skills, f luent in communication in English and Spanish (writing & speaking - B2+).
- Excellent knowledge of MS Office, Excel, and computer syste ms.
- Previous experience leading programs and projects for quality functional groups.
- Quality management or document control experience.
- Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to quality and compliance processes or programs Team player.
- Knowledge of FDA and Regulations.
- Audit - Quality and Compliance experience.
- Corrective and Preventative Action (CAPA).
- Technical Writing experience.
**Nice to Have**
- Strong typing skills and ability to write b
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