• Job Tag: #LI-CF1
• Posted: July 01,2025

We’re partnering with a local medical device contract manufacturer to find a new Quality Engineering Manager that can lead an experienced team of QE’s and Technician’s while supporting operations. 

• Develop and maintain policies that support business goals and meet regulatory requirements.
• Oversee QMS processes like complaint handling, design and development, change control, risk management, CAPA, supplier quality, process control, document control, and traceability.
• Coordinate effective investigations, root cause analysis, risk assessments, and timely corrective and preventive actions.
• Review and manage process validations (IQ/OQ/PQ) and quality control plans.
• Maintain dashboards and KPI’s to monitor trends, and coach the team for improvements.
• Support supplier qualification, selection, monitoring, and help resolve any quality issues.
• Represent the company during external audits with customers, regulatory authorities, and certification bodies.
• Monitor QMS compliance and effectiveness, ensuring alignment with ISO 9001, ISO 13485, FDA QSR (21 CFR 820), and other standards.
• Foster a culture of operational excellence using lean and six sigma principles.
• Support and maintain our Quality System, ISO compliance, and medical device regulatory requirements.

Requirements:

• Bachelor’s degree in Engineering, or a related field.
• 8+ years of experience in Quality or manufacturing/engineering in a regulated environment.
• At least 5 years in a leadership role managing teams.
• Strong knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, and GMP.
• Hands-on experience with auditing, supplier quality, writing procedures, and process validation.
• Familiarity with quality tools such as sampling plans, root cause analysis, DOE, statistics, Lean, and Six Sigma.
• Proven leadership skills and ability to build strong, effective teams focused on continuous improvement.