Senior Manager of Complaint Handling
- United States of America – Home Based
Job Title: Senior Manager or Complaint Handling
In this role, you have the opportunity to
To improve complaint operations, a Sr. Manager of Complaint Handling is required to focus on the activities supporting the Complaint Operations Function. This role is responsible for achieving critical KPIs and compliance to applicable regulations.
You are responsible for
- Manages a team of individual contributors supporting complaint operation activities such as; new complaint handling employee onboarding, training, complaint process ownership, complaint handling database SME, records review, and continuous improvement of processes, procedures, and tools.
- Monitors metrics and drives process improvements based on performance trends.
- Leading the team as a people manager, motivating the team and ensuring through good leadership that defined performance outcomes are ensured.
- Drive product quality improvements and support quality-based processes to ensure the highest quality of our products and solutions as well as compliance with all applicable regulations and requirements. This includes teaming up with business partners to share feedback in order to improve product performance.
- Ensure proper analysis of product quality, safety, and reliability issues and effective communication to management and other functions.
- Initiate and facilitate corrective or preventative actions as needed.
- Ensure quality customer and regulatory communications.
- Assisting in the development and implementation of strategic goal and objectives.
- Establishes and assures adherence to budgets, schedules, work plans, and performance requirements.
- Support and participate in internal and external audits.
You are a part of
You will be part of the Monitoring and Analytics & Therapeutic Care business group management team and will report directly to the Head of Complaint Handling.
To succeed in this role, you should have the following skills and experience
- Management and strong leadership skills in a challenging working environment with a proven track record of 3+ years of experience in managing complaint handling team with responsibilities covering training, complaint process ownership, TrackWise SME.
- 7+ years of related experience in a medical device or regulated industry preferably in combination with Post Market Surveillance and related processes.
- 3+ of daily usage of electronic complaint handling system, preferably TrackWise
- Experience in working under compliance enforcement such as; Consent Decree, Warning Letter
- Working knowledge of appropriate global medical device regulations, requirements, and standards, such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO14971, European Medical Device Directive (93/42/EEC), Canadian Medical Devices Regulation (SOR/98-282), Japanese MHLW Ordinance 169;
- Has wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways.
- Strong interpersonal and communication skills at all levels in the organization, a real people manager.
- Good analytical skills and process improvement capabilities with the ability to resolve complex issues in creative and effective ways.
- Strong written and oral communications skills.
- High reliability and quality focus.
- High engagement, motivation and flexibility.
In return, we offer you
The opportunity to manage a team currently going through rapid growth. This person will be trusted to implement a strategy to improve regulatory compliance and process efficiency. This person will be collaborating with post market leadership to transition the organization to meet EU MDR post market surveillance compliance.
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, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.
It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to age, color, citizenship, disability or perceived disability, ethnicity, gender, gender identity or expression, genetic information, marital or domestic partner status, military or veteran status, national origin, pregnancy/childbirth, race, religion, sexual orientation, or any other category protected by federal, state and/or local laws. Philips is an equal employment opportunity and affirmative action employer Disability/Veteran.