Quality Systems Engineer – CAPA, Training & Docs

Biomerics; Brooklyn Park, Northern (MN, KY); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Biomerics is seeking a Quality Engineer to oversee CAPA, Nonconforming Material, Document Control, and Training programs. This role acts as a Subject Matter Expert, driving system improvements and supporting internal audits across cross-functional teams to ensure compliance with product and quality requirements.

The position involves collaboration with R&D, Manufacturing Engineering, and Operations during concept to production transfer, including labeling, packaging, and supplier qualification

Qualifications

• Bachelor's Degree/Technical Degree in applicable field or equivalent industry experience
• Minimum 3 years' experience in a Medical Device manufacturing/product development environment
• Working knowledge of FDA QSR's, ISO 13485, and ISO 14971 requirements
• Experience with Nonconforming Material, Corrective and Preventive Actions, Training for both Direct and Indirect Labor, and working knowledge of Quality Management System software.
• Experience/knowledge with product/process verifications/validations
• Experience with development and support of Quality Systems as they relate to standards
• Must possess good project management skills and initiative in taking on and completing projects
• Must possess advanced verbal and written communication skills
• Must be able to manage and prioritize multiple projects/objectives

Responsibilities

• Direct oversight of the Nonconforming Material and Corrective and Preventive Action system.
• Direct oversight of the Direct and Indirect Labor Training program.
• Ownership of the document control quality management system.
• Initiate and drive improvements to systems supported by this role.
• Act as primary Subject Matter Expert on systems supported by this role.
• Participate as backup Internal Auditor as time permits.
• Work with cross functional teams to develop or improve quality systems related to standards and current business needs.
• Participate on Manufacturing Engineering/Operations teams to assure customer product requirements as well as quality requirements are documented and addressed.
• Interface with customer on labeling design, development, and packaging considerations.
• Collaborate with Supplier Quality to assure all new suppliers are qualified and that new components and materials are adequately qualified.
• Work with Manufacturing Engineering, Operations and QC Inspection in the development and qualification of processes.
• Assist with the development of inspection processes and equipment if and when required.
• Work with R&D, Manufacturing Engineering, Operations, and Quality, during concept, prototyping, and transfer of new products into production.
• Other assignments as requested.

Skills

CAPA

Nonconforming Material

Document Control

Training programs

Internal Audits

Quality Management System

Project Management

Verifications/Validations

Communication

Education

Bachelor's or Technical Degree

Tools

Quality Management System software

Job description

Biomerics is seeking a Quality Engineer to oversee CAPA, Nonconforming Material, Document Control, and Training programs. This role acts as a Subject Matter Expert, driving system improvements and supporting internal audits across cross-functional teams to ensure compliance with product and quality requirements.

The position involves collaboration with R&D, Manufacturing Engineering, and Operations during concept to production transfer, including labeling, packaging, and supplier qualification