Medical Device Quality Engineer: QMS & CAPA Lead

JBL Resources; Kalamazoo (MI); On-site; USD 75,000 - 110,000; Full time

Job summary

JBL Resources in Kalamazoo, MI seeks a Quality Engineer to support quality systems and manufacturing processes for medical devices. This role focuses on document control, QA audits, and continuous improvement across operations.

You will ensure compliance with ISO 13485, FDA regulations, and GMP, lead supplier quality initiatives, and drive root-cause analysis and CAPA activities to optimize product quality and manufacturing efficiency.

Qualifications

• Bachelor of Science degree in engineering preferred.
• At least 3 years of quality-related experience.
• Experience in medical devices or a similar regulated industry.
• Strong understanding of ISO 13485, FDA, and GMP requirements.
• Lean manufacturing experience; certification is not required.
• Ability to work independently and manage multiple priorities.
• Advanced proficiency with Microsoft Office.
• Clean room experience is a plus.

Responsibilities

• Overseeing and supporting the company’s document control processes.
• Managing label development and validation and supporting manufacturing when issues arise.
• Managing package testing and related activities, including equipment sourcing, qualification, and support, while serving as the in-house package-testing expert.
• Managing environmental monitoring for particulate and bioburden levels, along with cleanroom maintenance.
• Reviewing and approving SOPs to ensure alignment with corporate, site, and regulatory requirements.
• Leading monthly and quarterly continuous improvement initiatives.
• Identifying and communicating system improvements that promote efficient and effective practices while meeting compliance and business timeframes.
• Supporting NCR, CAPA, and complaint processes by providing root-cause analysis and identifying and implementing continuous improvement initiatives and production efficiencies.
• Supporting supplier quality issues, including SCARs, by leading problem-solving processes to identify problems and root causes and implement effective, sustainable corrective actions.
• Maintaining and tracking company quality metrics and reporting performance to management.
• Assisting with internal audits and supplier qualification audits to ensure compliance with ISO, FDA, and the QMS.
• Supporting the development of new product lines by ensuring that quality requirements are considered and attainable.
• Supporting operations with critical quality issues to ensure the effective manufacture of medical devices.
• Conducting and supporting training on QSR and ISO topics.
• Establishing and maintaining effective working relationships with Production and Warehouse/Distribution staff, corporate and site Quality teams, study management, and regulatory affairs.

Skills

Problem-solving

Decision-making

Critical-thinking

Communication

Planning

Organizational skills

Education

Bachelor of Science in Engineering

Tools

Microsoft Office

Job description

JBL Resources in Kalamazoo, MI seeks a Quality Engineer to support quality systems and manufacturing processes for medical devices. This role focuses on document control, QA audits, and continuous improvement across operations.

You will ensure compliance with ISO 13485, FDA regulations, and GMP, lead supplier quality initiatives, and drive root-cause analysis and CAPA activities to optimize product quality and manufacturing efficiency.