Medical Device Quality Engineer — CAPA & Systems Lead

Biomeric; Brooklyn Park (MN); On-site; 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 serves as a Subject Matter Expert, drives system improvements, and supports internal audits.

The engineer will collaborate with cross functional teams to ensure compliance with FDA QSRs, ISO 13485, and ISO 14971, support new product introduction, and assist in process and inspection development.

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 management

Nonconforming Material

Training programs

Internal Auditor

Cross-functional collaboration

Process improvement

Customer interfacing

Education

Bachelor’s Degree/Technical Degree in applicable field

Tools

QMS software

Job description

Biomerics is seeking a Quality Engineer to oversee CAPA, nonconforming material, document control, and training programs. This role serves as a Subject Matter Expert, drives system improvements, and supports internal audits.

The engineer will collaborate with cross functional teams to ensure compliance with FDA QSRs, ISO 13485, and ISO 14971, support new product introduction, and assist in process and inspection development.