Clinical Quality Lead (Colorado Springs, Plymouth, or San Diego hybrid)The Clinical Quality Lead will develop project management, leadership and interpersonal skills by driving clinical quality system activities (i.e. procedures), system activities, and process improvements for Philips’ Image Guided Therapy Device (PIGT-D) business unit. The role will be responsible for working with individual sites within the business unit to ensure the clinical processes are compliant to the regulations, and clinical teams are adhering to the procedures, regularly providing process insights to upper leadership as well as focusing on individual career growth.Your role:
Clinical QMS process and procedure support and compliance expert for the business
Support all regulatory agency audits of clinical activities
Provide feedback to users on process compliance and non-compliance
Other defined miscellaneous duties
You're the right fit if:
You’ve acquired 5+ years of related clinical studies regulations experience in medical device or other regulated industry. Experience working with class 3 PMA products and the accompanying clinical studies regulations is required.
Your skills include strong understanding of appropriate global regulations, requirements, and standards such as CFR Parts 803, 806, and 820, ISO 13485, and ISO 14971.
You have a bachelor’s degree or higher in a related field.
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) position.
You’re an excellent communicator (written and verbal) with a demonstrated ability to partner with the business and effectively interact with and influence employees, and managers on all levels.
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 (https://www.philips.com/a-w/about.html) .
Discover our rich and exciting history. (https://www.philips.com/a-w/about/our-history.html)
Learn more about our purpose. (https://www.philips.com/a-w/about/environmental-social-governance/our-purpose)
Read more about our employee benefits (https://www.careers.philips.com/na/en/best-employee-benefits) .
If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here (https://www.careers.philips.com/global/en/diversity-and-inclusion) .Philips Transparency DetailsThe pay range for this position is $96,850 to $200,256, annually. The actual base pay offered may vary 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 (https://www.careers.philips.com/na/en/best-employee-benefits) .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 posted location.#LI-PH1It 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
