Staff Quality Systems Engineer

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Job Function:
Quality

Job Sub Function:
Quality Systems

Job Category:
Professional

All Job Posting Locations:
Danvers, Massachusetts, United States of America

Job Description:

We are searching for the best talent for a Staff Quality Systems Engineer to lead and optimize CAPA and Nonconformance (NC) processes within a regulated medical device environment.

This role will be based in Danvers, MA.

Purpose: This role is instrumental in driving quality system improvements, ensuring global regulatory compliance, and mentoring junior engineers.

The position includes travel to support cross-site initiatives, supplier quality activities, and audit readiness.

You will be responsible for:


* Lead complex investigations of product and process nonconformances using advanced root cause analysis methodologies (e.g., Fault Tree Analysis, 5 Whys, Fishbone, DOE).


* Oversee the end-to-end CAPA and NC process, ensuring timely execution, thorough documentation, and effective implementation of corrective and preventive actions.


* Serve as a subject matter expert (SME) for CAPA and NC processes during internal audits, FDA inspections, and Notified Body assessments.


* Analyze CAPA/NC trends and metrics to identify systemic issues and recommend strategic quality improvements.


* Collaborate with cross-functional teams including Manufacturing, R&D, Regulatory Affairs, and Supplier Quality to resolve quality issues and implement sustainable solutions.


* Support risk management activities in accordance with ISO 14971, including risk assessments related to CAPAs and NCs.


* Mentor and train junior quality engineers and other stakeholders on CAPA/NC processes, regulatory requirements, and quality tools.


* Contribute to the development and continuous improvement of the Quality Management System (QMS), including SOPs, work instructions, and templates.


* Lead or support global harmonization initiatives for CAPA/NC processes across multiple sites or business units.


* Up to 10% travel may be required to support:
+ Regulatory inspections and internal audits at other facilities
+ Training and collaboration...