Quality Assurance Analyst, 3
Job TitleQuality Assurance Analyst, 3
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.
You are responsible for:
- Communicates with clarity & purpose demonstrating strong written & oral communication skills.
- Completes tasks related to record completion validation. 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.
- Demonstrates the Philips behaviors of eager to win, teaming up to excel and taking ownership.
- Fulfills all designated product and related training requirements (TMS)
- Functions as an active member of the team and shares knowledge and experience to resolve potential issues within the review process.
- Generating actionable quality data for product quality trends and improvement.
- Learns basic knowledge of products, how each system functions, tools and processes.
- Maintains confidentiality of all service records and pertinent information.
- Performs other related duties, projects and tasks as assigned.
- Provides a positive, cohesive company image when discussing Philips with internal customers.
- Takes ownership and accountability for their work.
- Takes ownership of complaints/potential complaints and works on resolution with the BIU within the appropriate timeframes.
- Team Player supporting team ideas & goals and contributes to team success.
- Understands the job requirements along with the customer and business needs. Demonstrates knowledge and skill by successfully completing assignments in a timely manner. Able to recognize problems and determine follow up actions with some direction.
- Understands the service delivery process and FDA regulations such as 820.200, 820.198.
- Develops a clear understanding of the CAPA process and assistance in the handling and tracking of CAPAs
- Exemplifies the Philips behaviors of eager to win, teaming up to excel and taking ownership.
- Strives to engage in and share continued product knowledge and support to the SRRT Initiative.
- Understands basic knowledge of products, how each system functions, tools and processes
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 2+ years experience in an administrative position with experience in a similar documentation/data driven position.
- Ability to multi-task and work in a fast-paced environment. Skill in prioritizing tasks required.
- Good clear and concise oral and written communications skills.
- Good organizational and time management skills.
- Intermediate 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.
- Intermediate knowledge of SAP required.
- Well versed in Q&R medical device terminology.
- Follows methods and procedures on new assignments.
- Works on assignments requiring considerable judgment and initiative. Understands implications of work and makes recommendations for solutions.
- Work well within a team environment to accomplish departmental goals.
- Able to work various shifts and 24x7 telephone coverage in a disaster situation.
- Ability to provide presentations and train individuals
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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Jose engineers the specific system level requirements for the Philips Sonicare oral healthcare products. He makes certain the detailed design of each device over-delivers on customer expectations every time.
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