In this role, you will have the ability to manage the company's quality management system in accordance with company and medical device regulatory requirements. Additional responsibilities include product regulatory submissions, certifications and approvals.
You are responsible for
Directly responsible for implementation, governance and maintenance of the company quality system, reporting on the performance of the quality system for review and as a basis for improvement of the quality system.
Ensure employees are aware of and comply with all RespirTech regulatory, customer requirements and regulations.
Sits on New Product Development Team for assigned products and provide Quality/Regulatory analysis on the Product Development Plan.
Direct responsibility of product submissions for approvals and clearances, including strategic regulatory planning and determination of the need for submissions. Responsibility to act as the liaison with external parties on matters relating to product submissions.
Provide primary input in identifying the standards that are applicable to RespirTech products and systems.
Provide Regulatory Training to business units and sales teams on regulations and standards as they apply to assigned products.
Responsibility to act as the liaison with external parties on matters relating to the quality system that include regulatory/client and third party audits. Act as Site Management Representative and coordinate all audits, inclusive of schedules, communication, reports and tracking follow-up actions.
Responsible for promotion of the quality and regulatory requirements through internal staff trainings.
Interface with Business Unit functions as needed to resolve regulatory concerns for assigned products.
Analyze and recommend appropriate changes of the procedures/processes to respective managers as they relate to regulation changes.
Develop and maintain the internal audit function and identify improvement opportunities.
Remain current in all aspects of regulatory and quality system requirements.
Develop and maintain corrective/preventative action program, inclusive of tracking status of open actions, receiving and reviewing responses, working with departments for timely completion and periodic reports.
Manage, motivate and lead direct reports.
Provide ongoing supervision and counseling for employees, guiding them in current positions and assisting with career development and training.
You are part of
Philips is one of the world's leading healthcare technology companies. We are committed to understanding the technological and human needs of patients and caregivers and to delivering solutions that enable more confident diagnoses, more efficient delivery of care, and more positive user experiences. People focused. Healthcare simplified.
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.
Skills and experience
BSME or BSEE from an accredited college or university in a related field, or equivalent work experience.
Minimum of 8 years in a senior management role. A minimum of 8 years Quality/Regulatory medical device experience.
Demonstrate competency in decision-making, flexibility, planning and organizing, self-initiative and interpersonal skills.
Excellent organizational, writing and communication skills.
Strong analytical skills.
Ability to multi-task, prioritize tasks and quickly adjust in a rapidly changing environment.
Experience with budgets, control processes, quality systems and regulatory practices.
Demonstrated understanding of computer-related equipment, including but not limited to desktop computers, laptops, printers, servers, network systems, software, and electronic databases.
Proficient in MS Office
ISO 13485, 14971, CFR, QSR, CMDR training and working experience.
Risk Management training as it relates to the business requirements.
We offer you
Enjoy endless opportunities to learn, and develop your career in the directions to which you aspire. Philips Healthcare is a place where you will work with others whose far-reaching ideas and accomplishments have impacted over 200 million lives already. Please help us determine what’s next. Your ideas and ability to deliver will help to transform the future of healthcare, and allow you to create your own legacy.
Why should you join Philips?
Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum at http://www.philips.com/b-dam/corporate/corporateblog/2016/PhilipsChronicDisease_5.jpg . Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video .
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page at http://www.philips.com/a-w/careers/healthtech/working-at-philips/working-at-philips.html on our career website, where you can read stories from our employee blog at http://www.usa.philips.com/a-w/our-people/life-at-philips.html . Once there, you can also learn about our recruitment process at http://www.philips.com/a-w/careers/healthtech.html , or find answers to some of the frequently asked questions at http://www.philips.com/a-w/careers/healthtech/faq.html .
Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.
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.