Philips Site Lead Quality Systems Engineer 

United States, Colorado 

180686149

Site Lead Quality Systems Engineer
Job Description

As a Quality Engineer you are accountable for oversight of system and hardware quality and risk management throughout the product life cycle.

Your role:

• Formulating and implementing the Business’ long-range quality and compliance policy and creating Quality awareness level as determined within the organization. Formulating and recommending changes to policies, while establishing procedures that affect immediate organization(s).
• Providing independent oversight of the design input process, design V&V activities, design transfer and product realization, and performance to ensure that all design requirements are effectively met.
• Enforcing quality systems and harmonizing them across the Business sites and Sector, while establishing an effective Management Review process, including routine reporting.
• Introducing and implementing the quality processes and tools required to ensure product quality and customer satisfaction.
• Managing compliance of FDA regulations and other Regulatory Agencies as required, guidelines and policies to all products and operations are consistent with those regulations, while managing all inspections and questions relating to the operation of the manufacturing sites. Coordinating efforts with all other applicable company groups to ensure completion.
• Receiving assignments in the form of objectives and determines how to use resources to meet schedules and goals.

You're the right fit if:

• You’ve acquired 4+ years of experience in medical device or highly regulated industry focusing on quality functions, maintenance and/or improvements of quality management systems and have supported regulatory audits/inspections.
• Your skills include experience with class III medical devices/combination devices, basic understanding of the global medical regulations, requirements, and standards
• You have a Bachelor of Science degree or equivalent years of experience managing and/maintaining quality management systems in a highly regulated environment.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
• You’re an excellent communicator, both written and verbal and have the ability to present to management teams.

How we work together

This is an office role.

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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The pay range for this position in Colorado Springs, CO is $80,000 to $136,000.

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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.