Philips Complaint Investigations in Baltimore, Maryland
As the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they improve.
We challenge you to support the Philips’ Hospital to Home (H2H) business unit as a Complaint Analyst. You will evaluate and resolve complaints, initiate CAPAs, analyze complaint data, gather additional data as needed, and provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations.
Working in the medical industry brings much fulfillment, as well as unique challenges. As part of our HealthTech-focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the US Federal Drug Administration (FDA).
Key areas of responsibilities for this role include:
Working with a variety of diverse roles within the company such as Engineers, Scientists, Clinical Specialists, Field Service Engineers (FSE) & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally
Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
Communicate with customers, call center reps and FSEs to gather more data on complaints as needed
Determine if OEM notification is required and if so contact the device manufacturer
Evaluate complaints for medical significance and determine if complaints meet reporting requirements/constitute an adverse event in consultation with clinical specialists as needed
Confirm complaint condition and determine corrective action (including CAPA as needed)
Communicate with complainant as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
Complete all needed records in a timely and accurate manner
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 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 the world.
You will report directly to the Director of Quality & Regulatory within Philips Hospital to Home (H2H) business. The H2H team is part of Philips Healthcare Informatics, Solutions & Services (HISS) division. This position is based in Baltimore, MD.
We are looking for:
A person who is excited about the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience in challenging, often demanding situations. We are looking for a perfectionist – a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life for the billions of people our brand touches every year.
Specific skill requirements for this role:
Bachelor’s degree or equivalent internationally-acquired qualifications in a Quality Assurance, Regulatory Affairs and/or science related field
3 years or more experience in an FDA/ Internationally regulated industry in the Postmarket Compliance area.
Knowledge of external regulations and standards relevant for our products including knowledge of FDA regulations, Medical Device Directive and ISO Quality System Standards.
Ability to read, interpret, understand, and implement regulations and regulatory requirements, documents such as safety rules, operating and maintenance instructions, and procedure manuals.
Computer skills: Microsoft Office, familiarity with Internet research.
Must be able to generate technical reports and protocols; strong verbal and written communication skills; ability to multitask and work under deadline restrictions.
Must be able to travel based on business needs.
This role comes with a competitive compensation offering and a generous holiday/vacation offering, but that is not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional lines, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.
Here at Philips WE ARE Working Together for a Better Tomorrow:
Philips' dedication to enriching lives is reflected in our company, our solutions, and a commitment to our people. Philips products lead to improved healthcare, faster diagnosis and better patient outcomes. Philips employees change lives every day.
Advance your career in an environment that supports work-life balance, health & well-being and continuous learning. Making a difference begins right here, where you come first.
Ready to start improving lives by putting your personal skills & passions to work?
Find out more info about Philips at www.philips.com/na/careers
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.