Site Lead Quality Systems Engineer

$80,000 - $136,000/Yr

Philips - Colorado Springs, CO

Full-time - Mid Level

Onsite - Colorado Springs, CO

Repair and Maintenance

About the position

The Site Lead Quality Systems Engineer at Philips is responsible for overseeing system and hardware quality and risk management throughout the product life cycle. This role involves formulating and implementing long-range quality and compliance policies, ensuring adherence to FDA regulations, and managing quality processes to enhance product quality and customer satisfaction.

Responsibilities

• Formulate and implement the Business' long-range quality and compliance policy.
• Provide independent oversight of the design input process, design V&V activities, design transfer, and product realization.
• Enforce quality systems and harmonize them across Business sites and Sector.
• Establish an effective Management Review process, including routine reporting.
• Introduce and implement quality processes and tools to ensure product quality and customer satisfaction.
• Manage compliance with FDA regulations and other Regulatory Agencies, ensuring all products and operations are consistent with regulations.
• Coordinate efforts with applicable company groups to ensure completion of inspections and questions relating to manufacturing sites.
• Receive assignments in the form of objectives and determine resource usage to meet schedules and goals.

Requirements

• 4+ years of experience in medical device or highly regulated industry focusing on quality functions.
• Experience with class III medical devices/combination devices.
• Basic understanding of global medical regulations, requirements, and standards.
• Bachelor of Science degree or equivalent experience managing quality management systems in a highly regulated environment.
• Excellent written and verbal communication skills with the ability to present to management teams.

Benefits

• Generous PTO
• 401k (up to 7% match)
• HSA (with company contribution)
• Stock purchase plan
• Education reimbursement
• Annual incentive bonus