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The Sr. Program Manager- Design Control & Post Market Surveillance will play a critical role in ensuring the Quality, Safety, and compliance of Philips’ Sleep & Respiratory (S&RC) products through transformation of S&RC Quality Management System, with a focus on Design Control and Post-Market processes to an effective structure, meeting all quality and regulatory requirements as part of our Consent Decree Office (CDO).Your role:
As a critical member of the S&RC Consent Decree Organization (CDO), the Sr. Program Manager drives simplification, standardization, and compliance in the QS processes, with a focus on Change Control, CAPA, Complaints, Training, and Safety/ Risk Management processes.
The Sr. Program Manager provides vision, strategy, manages complex problems and addresses difficult issues through understanding broader implications, integrates self-audit findings into the new QMS and has technical depth in Quality leadership in medical device industry.
Acting as the Sr. Program manager, accountable for the program plan & schedule and resolving interdependencies with other processes in the quality system.
Represents Design Control and Post-Market projects in PMO governance mechanisms including tiered daily management. Acts as the single point of accountability to communicate status, escalations, etc. with executives at various levels within S&RC.
Reporting to the Program Director-Consent Decree, you will partner with Philips’ subject matter experts within and outside the CDO to ensure appropriate capability and change plans are in-place, as well as partnering with consultants to ensure the new system meets today’s compliance standards and has flexibility to accommodates future agency trends and guidance.
This Hybrid role may require travel up to 25%.
You're the right fit if:
You’ve acquired a minimum of 7 years’ experience in program/project management in FDA regulated Medical Device, matrixed organizations, with strong knowledge in quality systems, audit, site quality, QA, product development, operations, Design Control and Post market Surveillance/Complaints etc.
You have proven expertise in all aspects of program/project management, planning, and execution, demonstrating an outstanding record of project management success, both in results achieved and in use of professional methodology. PMP Certification preferred.
You have detailed knowledge of Quality System Regulations (ISO 9001, ISO 13485, 21 CFR Part 803, 806 & 820) and knowledge of medical device process requirements.
You’ve influenced of a broad range of stakeholders, able to effectively communicate at all levels, including executive business/market leaders and content experts.
You’re a self-starter, skilled in driving continuous improvement in a matrixed environment, leading process improvement methodologies (e.g., Lean, Hoshin or 6-sigma).
You have a minimum of a Bachelor’s Degree (required), Master’s degree (preferred).
You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position (https://www.careers.philips.com/na/en/office/remote-sedentary-work-physical,-cognitive-and-environmental-pce-job-requirements) .
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.
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 $107,000 to $199,000, 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.#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
