Quality Engineer Location: Kalamazoo, Michigan About Our Client: 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. Key Responsibilities: - 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 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. Qualifications: - 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 Interested Candidates please apply on our website at https://jobs.jblresources.com{cke-saved-href="https://jobs.jblresources.com"}. For more information about our services and great opportunities at JBL Resources, please visit our website: https://www.jblresources.com{cke-saved-href="https://www.jblresources.com"}. JBL Resources is proud to have earned the reputation of being a premier provider of top talent professionals in the fields of engineering, human resource