Quality Engineering Manager

Role Summary

In this role, you will lead the development and continuous improvement of quality engineering processes to ensure product quality and regulatory compliance. You will manage a team of engineers, drive initiatives to resolve complex quality issues, and collaborate with cross-functional teams to maintain high-quality standards in product development and manufacturing.

Responsibilities

• Lead and manage the Quality Engineering team, providing direction and mentorship
• Develop and maintain quality engineering processes for compliance and improvement
• Drive initiatives to enhance product reliability, performance, and safety using engineering principles
• Lead root cause analysis and corrective action processes for quality issues
• Collaborate with R&D, Manufacturing, and Regulatory Affairs teams to meet quality standards
• Manage product qualification, validation, and verification for regulatory compliance (e.g., FDA, ISO 9001, GMP)
• Oversee design and implementation of quality testing methods and metrics
• Ensure adherence to risk management and process optimization best practices
• Review and approve quality documentation (e.g., technical reports, validation protocols)
• Develop and implement training programs on quality engineering practices
• Monitor and report quality performance metrics to identify improvements
• Stay current with industry regulations and best practices in quality engineering

Qualifications

• Education: Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, or related field
• Experience: 6+ years of experience in quality engineering, with 2+ years in a managerial or team leadership role in a regulated industry (e.g., pharmaceuticals, medical devices)
• Regulatory Knowledge: Knowledge of quality engineering principles and regulatory standards (e.g., FDA, GMP, ISO 13485/9001)
• Leadership: Experience leading cross-functional teams and managing quality projects
• Technical Expertise: Expertise in quality systems, process validation, and statistical analysis
• Problem-Solving: Strong skills for driving root cause analysis, corrective actions, and improvements
• Tools: Proficiency in Microsoft Office Suite (e.g., Word, Excel, PowerPoint) and quality management software
• Communication: Excellent skills for presenting technical information to management and stakeholders
• Adaptability: Ability to manage multiple projects in a fast-paced environment

Education

• Bachelor’s degree in Engineering, Quality Assurance, Life Sciences, or related field

Additional Requirements

• Primarily office-based with required time in GMP spaces addressing quality engineering and documentation
• Requires prolonged periods of computer use for data analysis, reporting, and documentation
• May involve lifting equipment or materials up to 20 pounds
• Ability to navigate office and GMP environments for inspections and coordination