Head of Complaint Handling
- United States of America – Home Based
- Full time
Head of Complaint Handling
In this role, you have the opportunity to:
The Head of QA/QE, Complaint Handling develops the organizational policies & standards and authorizes their implementation to ensure safe and reliable products, in compliance with regulatory requirements and Philips’ Business Systems/procedures in the area of complaint handling practices for medical devices.
For this, you will need excellent influencing skills, in-depth knowledge of meaningful Quality Assurance practices, a working knowledge of the regulatory context and understanding of complaint handling and post-market surveillance for medical devices.
You are responsible for:
- Establishing methodologies for day-to-day complaint management of quality, technical and adverse event complaint records, including intake, follow up, triage and entry, in accordance with local and international regulations, guidelines, and applicable directives.
- Execute the process to receive initial complaint from any source (external and internal) and ensure all information/data is accurately collected at point of contact.
- Maintain an understanding of information/data required to be collected for technical and adverse events/ reportable complaints to ensure compliance with regulations and directives.
- Establishing the process to review complaint data, assess for reportability and call out to the safety teams for reportability assessment.
- Ensure execution of intake / follow up / data entry activities and corresponding source documents in a timely manner per requirements and directives.
- Responsible for leading call triaging process from all sources for quality technical complaint, Adverse Event, request for refund, request for replacement product and request for credit.
- Establishing a methodology to Reviews data entry and follow-up activities for completeness and timeliness.
- Ensures customer feedback files are closed according to established guidelines to meet required timelines.
- Maintains a working knowledge of company policies and procedures
- Informs leadership of potential safety issues, emerging trends and/or concerns.
- Maintain state-of-the-art processes regarding Complaint Handling
- Distinguished by additional specialized knowledge in breadth and/or depth, as well as record of success in relevant business process/function.
- Viewed as an authority in the field and may be tasked with introducing new concepts. May have a leadership role.
- Regularly interacts with senior management or executive levels on matters concerning several functional areas, divisions, and/or customers.
You are a part of:
As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear collaborates 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.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree required in science or engineering fields. Master’s preferred.
- Familiarity with global medical device regulations, requirements, and standards to support process planning and resource designation a distinct advantage
- 10+ years of experience
- Ensure an engaged, innovative, and inspiring working environment by motivating, challenging, and coaching leaders and the organization as a whole
- Serves as the best practice/quality resource within own discipline or as technical guide on functional or cross-functional teams or projects
- Experienced knowledge of Complaint Handling Principles and practices including Adverse Event Reporting and Trending.
In return, we offer you
A path towards your most rewarding career. Philips is growing its marketing capability enterprise-wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer strong health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.
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. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.
To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
Philips is an equal opportunity employer. All 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.