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Quality Engineer - Minneapolis, United States - Medix
Description
Summary Statement:
Join our dynamic team and play a pivotal role in ensuring the compliance of our Quality Management System (QMS).
We're seeking a dedicated individual to collaborate closely with our small team, ensuring adherence to regulatory standards and maintaining the highest quality standards on-site, full-time.
This role is crucial in upholding the Quality System Manual procedures and ensuring strict compliance with its stipulations.Primary Responsibilities:
Complaint Handling and Returned Goods Authorizations (RGAs):Oversee complaint handling module, managing the entire process from entry to investigation, reporting, and trend analysis.
Conduct evaluations of returned devices.
Supplier Management:
Implement comprehensive supplier controls, including performance monitoring, credential reviews, and agreement establishment.
Develop risk-based sampling plans for receipt inspection procedures and manage supplier management system.
Conduct remote and on-site supplier audits, including planning and report generation.
Document Coordination, Reviews, and Approvals:
Facilitate formal Document Change Reviews (DCRs) using the Grand Avenue Software (GAS) platform.
Initiate and review DCRs for various documents, including SOPs, manufacturing procedures, and technical documentation.
Assist with GAS platform administration and manage different modules within it.
Corrective and Preventative Actions (CAPAs):
Investigate CAPAs, conduct root cause analyses, implement corrective/preventative actions, and verify their effectiveness
Gap Assessments:
Review relevant standards, regulations, and guidance documents to assess their impact on QMS and implement necessary changes.
Non-Conforming Materials (NMRs):Issue and approve NMR dispositions, including risk assessments and rework instructions
QMS Training Coordination:
Assist in coordinating training tasks, deliver training presentations, and oversee training quizzes
Secondary Responsibilities:
Perform receiving inspection activities, manage electronic production inventory systems, and assist with purchasing activities.
Maintain and manage quality records related to QMS and production activities.
Participate in risk management activities and audits, including notified body, FDA, and internal audits.
Support management review processes through data analysis and presentation preparation.
Provide assistance with production operations, order fulfillment, and field action activities.
Qualifications:
Bachelor's degree in engineering or relevant discipline, or equivalent experience/certifications.
Experience in medical device industry with quality management systems.
Strong knowledge of medical device regulations, including EU MDR and US 21 CFR Part 820, as well as ISO 13485.Experience with Grand Avenue Software (GAS) Electronic Quality Management System preferred but not required.
Ability to work independently and in a team environment, with excellent communication skills and proficiency in Microsoft Office applications.Join our team and contribute to the maintenance of our high-quality standards in the medical device industry#J-18808-Ljbffr