Site Lead Quality Systems Engineer

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 togetherWe 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 PhilipsWe 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.

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Learn more about our commitment to diversity and inclusion.

Philips Transparency DetailsThe 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 InformationUS 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 .It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person’s relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.Equal Employment and Opportunity Employer/Disabled/Veteran