Quality Engineer

Location:

Kalamazoo, Michigan

Our client is a West Michigan-based medical device manufacturing and product development company specializing in the assembly, packaging, and sterilization of medical products. With a strong focus on quality, innovation, and collaboration, they partner with customers to deliver reliable solutions that support the healthcare industry. Their team values continuous improvement, technical expertise, and a collaborative work environment.

• Overseeing and supporting the company’s 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 time frames.
• 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.

• Bachelor of Science degree; an engineering discipline is 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.
• 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

JBL is an Equal Opportunity Employer and E-Verify Company