Ingénieur Qualité II

## Ingénieur Qualité IIPostuler:
Sur site:
Mystic, Connecticut, United States of America:
Temps plein:
Offre publiée hier:
Date de fin : 25 septembre 2026 (Il reste 7 jour(s) pour postuler):
R77682

We anticipate the application window for this opening will close on - 25 Sep 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
** The Mystic site is part of the Ear, Nose and Throat business and manufactures Merocel sponge Class I medical devices used to support patient care. The Quality function partners with manufacturing, engineering, and operations teams to maintain compliance, support product quality, and drive continuous improvement across quality system processes.
This position is based in Mystic, Connecticut and requires onsite support five days per week to effectively partner with cross-functional teams and support manufacturing operations. No travel is required for this role.
As a Quality Engineer II, you will support quality system activities within a regulated medical device manufacturing environment, with a focus on nonconformance management, corrective and preventive action (CAPA), calibration, process and equipment validation, and compliance with applicable regulatory requirements. This role collaborates across functions to maintain quality system effectiveness, support manufacturing operations, and drive continuous improvement initiatives.
** Primary Responsibilities
*** Support nonconformance investigations and partner with cross-functional teams to identify root causes and implement corrective actions.
* Facilitate Corrective and Preventive Action (CAPA) activities, including documentation, effectiveness verification, and closure.
* Maintain compliance of calibration programs and support calibration-related quality activities.
* Execute and support process and equipment validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and related validation documentation.
* Collaborate with manufacturing and engineering teams to establish, implement, and maintain product and process quality requirements.
* Develop, revise, and maintain quality documentation, procedures, and records to ensure compliance with quality system requirements.
* Analyze quality data and trends to identify improvement opportunities and support risk-based decision-making.
* Participate in internal audits, inspections, and regulatory readiness activities to ensure ongoing compliance.
** Required Qualifications
*** Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
* Experience supporting quality system processes within a regulated manufacturing environment.
* Experience with nonconformance investigations, root cause analysis, and corrective action implementation.
* Working knowledge of quality documentation requirements and regulatory compliance standards.
* Ability to manage multiple projects and priorities while maintaining accurate and compliant documentation.
** Preferred Qualifications
*** Experience with in the medical device industry.
* Working knowledge of Track Wise quality management systems.
* Experience using SAP to support quality, manufacturing, or calibration activities.
* Knowledge of calibration management and process or equipment validation activities.
* Strong analytical skills with experience evaluating quality data and driving process improvements.

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