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Sr. Quality Compliance Manager (U.S. Hub Location) The Senior Manager of Quality Compliance underpins the overall quality culture within the Hospital Patient Monitoring business by teaming with professionals from other sites and functions to move the business forward utilizing compliant, workable solutions. This role provides guidance to all levels of personnel within the organization, so the ideal candidate has a working knowledge of how to meet regulatory requirements in a practical, non-burdensome way, so they can advise on the best solutions for the business.Your role:
Providing strategic oversight to the Ambulatory Monitoring & Diagnostics (AM&D) organization on how to operationalize a quality compliance mindset. Enabling the use of the quality management system by driving streamlined and improved processes; providing input to those processes which are not personally owned/managed.
Providing guidance to end users on how to correctly execute compliance processes (I.E. CAPA, NCR/QN, Audit Finding resolution, MDR/MDV reporting, Training, Quality Planning, Management Responsibility requirements, etc.). Ownership and oversight of the Internal Audit, CAPA, and NCR programs.
Providing compliance guidance across the business as needed. Primary areas include quality system changes, large-scale projects, day-to-day general questions, and as the primary Quality voice for mergers and acquisitions. Leading and developing succession plans for the Compliance Team, as applicable.
Business Owner for all nonconformance management systems. Ensures compliance to 21 CFR 11 and local processes for any of those systems requiring electronic system validation. Collaborating cross-functionally to drive overall improvement in the Compliance arena, as applicable.
Owning, meeting, and reporting on business quality metrics as part of organizational goals and reporting meetings. Meeting forums include management review, CAPA Review board meetings, or other quality meetings at the business group level. Leading and coordinating external audits locally and as needed across the business group.
You're the right fit if:
You’ve acquired 7+ years of experience in relevant functions related to quality management systems, CAPA’s, nonconformance's, and auditing within the medical device industry. Experience managing projects within an FDA regulated environment is required.
Your skills include knowledge of QSR, ISO 13485, MDR, and other related regulations required. Strong CAPA knowledge and in-depth experience working with nonconformance's is a must. Experience with Arena is strongly preferred.
You have a bachelor’s degree or higher in a relevant 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. You have a proven capability to influence a broader organization through leading by example and raising the bar on what is considered acceptable within a medical device business. Ability to travel as needed (<10%).
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 $00,000 to $000,000, 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 locations. All United States-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips. Employees may request a reasonable accommodation. Montana employees, learn more here (https://www.careers.philips.com/na/en/philips-covid-statement) . 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
