Quality Assurance Analyst- Entry Level

Job description

Job Title

Quality Assurance Analyst- Entry Level

Job Description

Quality Assurance Analyst– Entry Level – Nashville, TN

This role is an entry level position into Quality Compliance in Medical Devices. You will be trained and able to effectively act as a member of the Quality & Regulatory team and be responsible for 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. Within this team you will gain knowledge and acumen on Medical devices, Regulations as well as be a part of a team with room for career growth.

In this Role you will:

• Become trained and Business Unit qualified in HHM coding by Philips

• Acquire basic knowledge of our medical device products, tools and processes

• Ensure data entered into cases is complete, accurate and of high quality to enable BIU to produce product quality trending reports for product improvements.

• Take ownership of complaints/potential complaints and works on resolution within the appropriate timeframes.

• Understand the service delivery process and FDA regulations such as 820.200, 820.198.

• Perform responsibilities and assigned tasks with minimal supervision.

• Participate in entry level project management including CAPA's, Kaizen and LEAN training.

You are responsible for:

•Communicating with clarity & purpose demonstrating strong written & oral communication skills.

•Completing 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.

•Demonstrating the Philips behaviors of eager to win, teaming up to excel and taking ownership.

•Fulfilling all designated product and related training requirements

•Functioning 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.

•Learning basic knowledge of products, how each system functions, tools and processes.

•Maintaining confidentiality of all service records and pertinent information.

•Performing other related duties, projects and tasks as assigned.

•Providing a positive, cohesive company image when discussing Philips with internal customers.

•Taking ownership and accountability for their work.

•Taking 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.

•Understanding 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.

•Understanding the service delivery process and FDA regulations such as 820.200, 820.198.

•Developing a clear understanding of the CAPA process and assistance in the handling and tracking of CAPAs

•Exemplifying the Philips behaviors of eager to win, teaming up to excel and taking ownership.

•Striving to engage in and share continued product knowledge and support to the SRRT Initiative.

•Understanding basic knowledge of products, how each system functions, tools and processes

You are a part of:

Complaint Handling investigates product complaints and interacts with colleagues on Key Markets / Field Service Engineers (contacting customer), Product Support Engineers (product application), R&D (product design, risk management), Marketing (Instructions for Use), Repair Bench (testing of returned products).

The investigator decides about reportability of incidents with patients / users – if necessary discussed with colleagues and Safety Officer / Deputies. Input for reports to Competent Authorities is given to the Adverse Event Coordinators.

In case of product problems and the necessity of a CAPA request there is a close cooperation with the CAPA owner (Corrective and Preventive Action) and the HHE owner (Health Hazard Evaluation).

Tasks are beside the complaint investigation and trending the participation in Cross Functional Teams and Product Trainings.

To succeed in this role, you should have the following skills and experience:

•A BS/BA or equivalent experience in Quality preferred.

•A minimum of 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).

•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:

This role comes with a competitive compensation offering and a generous holiday / vacation offering, but that's 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 to drive 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 areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by.

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

Contact

If you forgot your password, you can click the Forgot Password button on the Sign In screen to reset it. In case of technical difficulties, please send an email to .
(Note: To ensure fairness and legal compliance in our recruitment processes, only technical issues will be monitored through the above inbox. Please do not submit resumes or applications to this email, as they will not be reviewed. Only applications received through the online application process will be considered.)