Site Lead Quality Systems Engineer

Job TitleSite 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 position. 
• You’re an excellent communicator, both written and verbal and have the ability to present to management teams.

How we work together

We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.

This is an office role.

About Philips

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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our commitment to diversity and inclusion.

Philips Transparency Details

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

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

Additional Information

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.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO.

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.