Quality Audit Program Lead (U.S. Hub Based) This is an exciting opportunity to play a critical role in assuring international regulatory and legal compliance of Philips’ Quality System (QMS) and company-wide compliance with Philips quality-policies, objectives, and standards, contributing to improving and saving lives around the world.Your role:
Overall responsibility for managing the audit program/initiatives including scheduling, scope, report review, CAPA reviews and KPI/metrics. In addition, you will be responsible for monitoring of program needs, including training, qualification, and review of responses to audit findings for completeness and effectiveness.
As a member of Philips Quality Organization, you will collaborate with QMS leaders and auditees in all group functions, markets, and businesses. You will also interact/collaborate with auditees, central QA and CAPA facilitators as necessary.
There is <10% travel required for this role.
You're the right fit if:
You’ve acquired 7+ years’ Quality experience in FDA Regulated, Medical Device/Tech environments, 3+ years in functional leadership, focus on Program Management, and advanced understanding of global governing regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, 11; ISO 13485/14971/9001, European MDD (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169.
Your skills include developing/administering program schedules, adherence to budgets, schedulers, work plans, and performance requirements. Successful interface management with external parties (Notified Bodies, Regulatory Authorities, Healthcare Q&R Service Providers, etc.) Competence in Sharepoint and Power Apps is a plus.
Build, maintain, and provide insight by consolidating data and KPI metrics. Including tracking and analyzing KPI’s across audit program to show trends.
You have a bachelor’s degree or higher (required); advanced degree (preferred).
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 a self-starter with strong organizational leadership skills and skilled in driving continuous improvement in a matrixed environment, with the capacity to adapt to changing work requirements as needed.
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 (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 Details The 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 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 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
