Senior Quality Assurance Analyst, 5
Job TitleSenior Quality Assurance Analyst, 5
In this role, you have the opportunity to:
The person fulfilling this role is responsible for service record review ensuring quality records, identifying potential FDA reportable events and/or Business Unit follow up and escalation. This role is also responsible for corresponding with the Customer Care Solutions Center and Field Service Organization to ensure a complete and quality record.
The individual displays leadership capabilities through time management, organization and team development while driving process improvements and compliance.
You are responsible for:
- Understands and embraces the job requirements along with the customer and business needs. Demonstrates strong knowledge and skill by successfully driving the completion of assignments in a timely manner. Able to recognize problems while proactively applying effective solutions and determining follow up actions with minimum direction.
- Generating actionable quality data for product quality trends and improvement. An advanced in depth knowledge of cases & coding that closely aligns with the BIU.
- Takes ownership of complaints/potential complaints with a positive attitude and escalates to the BU within the appropriate timeframes.
- Completes tasks related to complaint handling and record completion validation. Advanced knowledge of the work order process is required. Able to assist the team as required.
- Exemplifies the Philips behaviors of eager to win, teaming up to excel and taking ownership in a role model capacity encouraging others to do the same.
- Understand the service delivery process and FDA regulations such as 820.200, 820.198.
- Communicates with clarity & purpose demonstrating strong written & oral communication skills using them to effectively & professionally address issues.
- Reviews information provided when a customer alleges a malfunction/defect or problem with the field performance of our medical devices. Ensures completion of the applicable 11 safety questions and follows up if required to ensure a complete record.
- Maintains confidentiality of all service records and pertinent information.
- Perform, manage, and coordinate other related duties, projects, and tasks as assigned
- Produce and distribute case assignments in a timely manner
- Maintain BIU and global Q&R SLA HHM coding standards in a minimum of two modalities
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 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.
To succeed in this role, you should have the following skills and experience:
- A BS/BA or equivalent experience in business preferred.
- At least 6 years' experience in an administrative position with experience in a similar documentation/data driven position.
- Prefer 3+ years experience in the quality field
- Ability to multi-task and work in a fast-paced environment. Skill in prioritizing tasks required.
- Excellent clear and concise oral and written communications skills.
- Excellent organizational and time management skills.
- Advanced skills in using MS Windows and Office (e.g., Word, Excel).
- Familiar with FDA regulations including FDA CFR: 820.803, 820.100 and 820.198, and 820.200.
- Advanced skills in SAP, Trackwise, Excel, word processing, or other productivity IT tools a plus.
- An expert in Q&R medical device terminology.
- Reviews methods and procedures and makes recommendations on process improvements.
- Works on complex assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions.
- Lead the team in accomplishing department goals
- Overtime required during month- and quarter- ends.
- Able to work various shifts and 24x7 telephone coverage in a disaster situation.
- Demonstrated ability to create, present and train individuals
- Demonstrated leadership capabilities
- One to two years in some form of supervisory role
In return, we offer you:
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).
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. 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 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.
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.
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