Site Lead Quality Systems Engineer

$80,000 - $136,000/Yr

Koninklijke Philips N.V - Colorado Springs, CO

Full-time - Mid Level

Onsite - Colorado Springs, CO

Ambulatory Health Care Services

About the position

The Site Lead Quality Systems Engineer is responsible for overseeing system and hardware quality and risk management throughout the product life cycle. This role involves formulating and implementing quality policies, ensuring compliance with 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 and design V&V activities.
• Enforce quality systems across Business sites and establish an effective Management Review process.
• Introduce and implement quality processes and tools to ensure product quality.
• Manage compliance with FDA regulations and other regulatory agencies.
• Coordinate efforts with applicable company groups to ensure compliance with regulations.
• Receive assignments in the form of objectives and determine resource allocation to meet goals.

Requirements

• 4+ years of experience in medical device or highly regulated industry focusing on quality functions.
• Experience with class III medical devices and combination devices.
• Basic understanding of global medical regulations, requirements, and standards.
• Bachelor of Science degree or equivalent experience in managing quality management systems.

Nice-to-haves

• Excellent written and verbal communication skills.
• Ability to present to management teams.

Benefits

• Generous PTO
• 401k with up to 7% match
• HSA with company contribution
• Stock purchase plan
• Education reimbursement