Medical Devices Quality Engineer - QMS, CAPA & CI Lead

JBL Resources; Kalamazoo (MI); On-site; USD 70,000 - 110,000; Full time

Job summary

JBL Resources is assisting a West Michigan-based medical device manufacturer in seeking a dedicated Quality Engineer with a focus on ISO 13485, FDA, and GMP compliance. The role emphasizes document control, supplier quality, and continuous improvement to ensure safe, effective products.

You will lead root-cause analyses, support CAPA and NCR processes, and help develop new product lines while coordinating with Production, QA, Regulatory, and supply chain teams.

Qualifications

• Bachelor of Science degree, engineering preferred.
• At least 3 years of quality-related experience.
• Experience in medical devices or similar regulated industry.
• Strong understanding of ISO 13485, FDA, and GMP requirements.
• Lean manufacturing experience; certification is not required.
• Strong problem-solving, decision-making, critical-thinking, communication, planning, and organizational skills.
• Ability to work independently and manage multiple priorities.
• Advanced proficiency with Microsoft Office applications.
• Clean room experience is a plus.
• NO C2C candidates.

Responsibilities

• Overseeing and supporting document control processes, including the management and flow of all QMS documents.
• Managing and being accountable for label development and validation while 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

Quality-related experience

Problem solving

Decision making

Critical thinking

Communication

Planning

Organizational skills

Independent work

Microsoft Office

Lean manufacturing

Clean room experience

Education

Bachelor of Science (Engineering preferred)

Tools

Microsoft Office

Job description

JBL Resources is assisting a West Michigan-based medical device manufacturer in seeking a dedicated Quality Engineer with a focus on ISO 13485, FDA, and GMP compliance. The role emphasizes document control, supplier quality, and continuous improvement to ensure safe, effective products.

You will lead root-cause analyses, support CAPA and NCR processes, and help develop new product lines while coordinating with Production, QA, Regulatory, and supply chain teams.