Medical Device Manufacturing Engineer

Radiant Dev; Seattle (WA); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental reimbursement

15 days of paid time off (PTO)

401(k) plan with pre-tax and Roth options

Job summary

A leading manufacturing company in Seattle is seeking an experienced Quality Assurance Engineer to oversee crucial elements of the Quality Management System, manage manufacturing nonconformances, and maintain regulatory compliance. The ideal candidate will have a Bachelor’s degree in relevant engineering fields or equivalent experience, along with a strong background in quality and manufacturing processes. This hybrid position offers a robust benefits package, including medical insurance and paid time off.

Qualifications

• 8+ years of relevant experience in manufacturing or quality roles.
• 3+ years in a regulated environment, preferably in medical devices.
• Clear, concise technical writing abilities.
• Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control.
• Familiarity with ISO 13485.
• Comfortable supporting internal and external audits.

Responsibilities

• Lead investigations into manufacturing nonconformances.
• Review and validate manufacturing processes for compliance.
• Manage supplier quality through evaluations and audits.
• Manage supplier quality, including evaluations, audits, and SCARs.
• Drive internal CAPAs tied to manufacturing issues.
• Track production data, identify trends, and drive continuous improvement.
• Train and support the team on QMS processes, GMP, and process controls.
• Maintain and improve manufacturing documentation, inspection procedures, and Device History Records.

Skills

Manufacturing and quality engineering experience

Detail-oriented mindset

Clear communication skills

Collaborative team player

Problem-solving skills

Education

Bachelor’s degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering

Tools

CAPA tracking

Document control systems

Job description

Overview

We are seeking a hands-on quality assurance engineer with strong manufacturing, root-cause analysis, and quality systems experience. This hybrid Quality/Manufacturing role owns key elements of the Quality Management System (QMS), including Nonconformance Management, Equipment Qualification/Calibration, Incoming and In-Process Inspection, and Supplier Quality, while contributing to improving product quality, cost, and manufacturability.

Responsibilities

• Lead investigations and manage dispositions for all manufacturing nonconformances.
• Review, optimize, and validate manufacturing processes for quality and regulatory compliance.
• Own tooling and equipment qualification and calibration.
• Manage supplier quality, including evaluations, audits, and SCARs.
• Drive internal CAPAs tied to manufacturing issues.
• Track production data, identify trends, and drive continuous improvement efforts.
• Train and support the team on QMS processes, GMP, and process controls.
• Maintain and improve manufacturing documentation, inspection procedures, and Device History Records.

Required Qualifications

• Bachelor’s degree in Manufacturing, Mechanical, Biomedical, or Industrial Engineering; or 8+ years of relevant experience.
• 3+ years in a regulated environment (medical devices preferred).
• Clear, concise technical writing skills.
• Working knowledge of QMS elements such as CAPA, Training, Nonconformance, and Change Control.
• Familiarity with ISO 13485.
• Comfortable supporting internal and external audits.

Skills That Will Make You Successful

• Practical experience in manufacturing and quality engineering.
• Detail-oriented mindset with a focus on mistake-proofing.
• Solid engineering fundamentals: materials, manufacturing, test methods, and root cause analysis.
• Clear communicator with both technical and nontechnical stakeholders.
• Collaborative team player and proactive problem solver.

The company provides a comprehensive benefits package, including medical insurance, dental reimbursement, 15 days of paid time off (PTO) plus federal holidays, and a 401(k) plan with both pre-tax and Roth options.