Espec. en sistemas de calidad
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-01-25
Listing for:
Medtronic plc
Full Time
position Listed on 2026-01-25
Job specializations:
-
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager, Regulatory Compliance Specialist
Job Description & How to Apply Below
Chez Medtronic, vous pouvez entamer une longue carrière d’exploration et d’innovation tout en aidant à soutenir l’accès aux soins de santé et l’équité pour tous. Vous dirigerez avec détermination en surmontant les obstacles à l’innovation dans un monde davantage connecté et compatissant.
** Journée type
** Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives.
As a Quality Systems Specialist, you will play a vital role in maintaining and enhancing the Quality Management System (QMS) to ensure compliance with regulatory requirements and internal standards. Your expertise will support audit activities, CAPA documentation, and reporting processes, contributing to the overall success of the organization's quality initiatives.
Responsibilities may include the following and other duties may be assigned.
* Provide 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.
* Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
* Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
* Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
* Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
* Co-ordinate legal requests in support of government investigations or litigations.
* Ensure the quality assurance programs and policies are maintained and modified regularly.
* Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
This role is
** 100% onsite
** at our Rice Creek, MN site and travel between the Twin City campuses as needed.
** Must Have:
Minimum Requirements
*** To be considered for this role, please ensure the minimum requirements are evident in your applicant profile.
** Bachelor's degree with 2+ years of work experience in Quality or regulated industry OR Advanced degree with 0+ years of work experience in Quality or regulated industry
** Nice to Have
*** Organize audit back rooms, prepare documentation, and facilitate communication between auditors and teams.
* Assist CAPA owners with documentation, ensure process compliance, and monitor timelines.
* Create and deliver accurate QMS reports to support quality initiatives and improvements.
** Exigences physiques du poste
** Les déclarations ci-dessus visent à décrire la nature générale et le niveau du travail effectué par les employés affectés à ce poste, mais elles ne constituent pas une liste exhaustive de toutes les responsabilités et compétences requises pour ce poste.
Les exigences physiques décrites dans la section Responsabilités de cette fiche de poste sont représentatives de celles auxquelles un employé doit satisfaire pour remplir correctement les fonctions essentielles du poste. Des ajustements raisonnables peuvent être apportés pour permettre aux personnes en situation de handicap de remplir ces fonctions essentielles. Rôles administratifs : dans l’exercice de ses fonctions, l’employé est régulièrement appelé à se déplacer de façon autonome.
Il est également amené à utiliser un ordinateur et à communiquer avec ses pairs et ses collègues. Contactez votre responsable ou votre service RH local pour connaître les conditions de travail et les…
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