Medix™
Overview
We're seeking a
Senior Quality Systems Engineer
to manage essential quality functions, including
CAPA ,
Nonconforming Material (NCM) ,
Document Control , and
Training programs . This role will act as a
Subject Matter Expert (SME) , driving system improvements and assisting with internal audits. You'll work closely with cross-functional teams to ensure compliance with product and quality requirements, support the introduction of new products, and help develop processes and inspection methods. Responsibilities
Lead and manage the
Nonconforming Material
and
Corrective and Preventive Action
systems. Oversee the
Direct and Indirect Labor Training
program. Maintain ownership of the
Document Control
quality management system. Initiate and drive improvements for the quality systems you support. Serve as the primary
Subject Matter Expert
for key quality systems. Support internal audits as a backup auditor when available. Collaborate with teams to develop and improve quality systems in alignment with industry standards and business needs. Work with manufacturing engineering and operations teams to ensure customer and quality requirements are properly documented and met. Interface with customers regarding labeling, design, development, and packaging. Coordinate with
Supplier Quality
to ensure new suppliers, components, and materials are qualified. Partner with
Manufacturing Engineering ,
Operations , and
QC Inspection
to develop and qualify processes. Assist in the development of inspection processes and equipment as needed. Engage with
R&D ,
Manufacturing Engineering , and
Operations
during the concept, prototyping, and transfer phases of new products into production. Requirements
Bachelor's Degree in an applicable field or equivalent industry experience. Minimum of 5 years of experience in a
Medical Device manufacturing
or
product development
environment. Strong working knowledge of
FDA QSRs ,
ISO 13485 , and
ISO 14971
requirements. Proven experience with
Nonconforming Material ,
Corrective and Preventive Actions , and
Training
systems, including knowledge of
Quality Management System (QMS)
software. Experience with
product/process verifications and validations . Experience in the development and support of
Quality Systems
as they relate to industry standards. Excellent project management skills and the ability to take initiative. Advanced verbal and written communication skills. Ability to manage and prioritize multiple projects and objectives. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries: Medical Equipment Manufacturing Location: Elk River, MN Salary: $90,000 - $105,000
#J-18808-Ljbffr
We're seeking a
Senior Quality Systems Engineer
to manage essential quality functions, including
CAPA ,
Nonconforming Material (NCM) ,
Document Control , and
Training programs . This role will act as a
Subject Matter Expert (SME) , driving system improvements and assisting with internal audits. You'll work closely with cross-functional teams to ensure compliance with product and quality requirements, support the introduction of new products, and help develop processes and inspection methods. Responsibilities
Lead and manage the
Nonconforming Material
and
Corrective and Preventive Action
systems. Oversee the
Direct and Indirect Labor Training
program. Maintain ownership of the
Document Control
quality management system. Initiate and drive improvements for the quality systems you support. Serve as the primary
Subject Matter Expert
for key quality systems. Support internal audits as a backup auditor when available. Collaborate with teams to develop and improve quality systems in alignment with industry standards and business needs. Work with manufacturing engineering and operations teams to ensure customer and quality requirements are properly documented and met. Interface with customers regarding labeling, design, development, and packaging. Coordinate with
Supplier Quality
to ensure new suppliers, components, and materials are qualified. Partner with
Manufacturing Engineering ,
Operations , and
QC Inspection
to develop and qualify processes. Assist in the development of inspection processes and equipment as needed. Engage with
R&D ,
Manufacturing Engineering , and
Operations
during the concept, prototyping, and transfer phases of new products into production. Requirements
Bachelor's Degree in an applicable field or equivalent industry experience. Minimum of 5 years of experience in a
Medical Device manufacturing
or
product development
environment. Strong working knowledge of
FDA QSRs ,
ISO 13485 , and
ISO 14971
requirements. Proven experience with
Nonconforming Material ,
Corrective and Preventive Actions , and
Training
systems, including knowledge of
Quality Management System (QMS)
software. Experience with
product/process verifications and validations . Experience in the development and support of
Quality Systems
as they relate to industry standards. Excellent project management skills and the ability to take initiative. Advanced verbal and written communication skills. Ability to manage and prioritize multiple projects and objectives. Seniority level
Mid-Senior level Employment type
Full-time Job function
Quality Assurance Industries: Medical Equipment Manufacturing Location: Elk River, MN Salary: $90,000 - $105,000
#J-18808-Ljbffr