Sr Quality Systems Engineer

## Sr Quality Systems Engineer Postulerremote type:
Sur site locations:
Lafayette, Colorado, United States of America time type:
Temps pleinposted on:
Offre publiée aujourd'huitime left to apply:
Date de fin : 31 juillet 2026 (Il reste 20 jour(s) pour postuler) job requisition :
R70930

We anticipate the application window for this opening will close on - 31 Jul 2026

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*
* ** Our purpose:
** Acute Care & Monitoring solutions, we empower healthcare professionals with world-class technology to personalize patient care, anytime, anywhere.  Our products can be found in various specialties:
Respiratory Therapy, Critical care physicians and nurses, anesthesia, operating room, emergency medicine, first responders, hospital administration, operating room clinicians, and procedural sedation  this exciting role as a Senior Quality Systems Engineer, it will be one of development, improvement, and innovation, through cross functional collaboration. If you pride yourself on your problem-solving skills, meticulous attention to detail and passion for quality this may be the role for you.

You will be tasked to provide quality systems engineering support in the development and maintenance of medical device products across the Acute Care and Monitoring (ACM) portfolio of products.
You will facilitate the application of our Quality Management System in developing and sustaining our product portfolio.  This position is in Lafayette, CO and requires on-site presence four days a week.
** A Day in the life of:
*** Manage and drive the Corrective and Preventive Action (CAPA) Program.  + CAPA Specialist position is expected to be an expert in  + CAPA scoping, root cause analysis, action planning & execution, and techniques for verification of CAPA effectiveness.  Able to mentor CAPA owners to ensure complete and defendable CAPAs including investigations, Root Cause Analysis and resulting Corrective and Preventive Actions, and developing sound effectiveness check plans.  

+ Effective communication of CAPA status to CAPA Board and escalation to applicable stakeholders.

Responsible for CAPA process expertise, and assists CAPA Owners with compliance to CAPA requirements, guidance, and best practices.
* Provides oversight into 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 technical expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to ensure compliance.
* Supports internal and external audits and inspections  + Managing and driving audit and inspection finding investigations and resolutions with a cross-functional team.
* Investigates and resolves compliance problems, questions, or complaints received from other units of the company, customers, government regulatory agencies, etc.
** Key skills and Experience
*** Requires a Level 8 degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
* Experience in the Medical Device Industry or a similar industry role
* CAPA ownership/execution experience, required
* Strong understanding of medical device regulatory and governmental regulations (EU MDR, FDA, MDSAP, ISO 13485, etc.)
* Experience in Risk Management ISO 14971
* Medical Device Auditing Experience
* Project Management experience
* Strong analytical and problem-solving skills, excellent communication skills, excellent writing and editing skills, and computer skills in the English language.
* Ability to work effectively independently, within teams, and across functions.
* Ability to travel on occasion
* Needs to be updated for US Based Candidates Pour les diplômes de baccalauréat…