Posted 3 months ago
Quality Assurance Record Reviewer
- United States of America – Home Based
- Full Time
In this role, you have the opportunity to
Continuously improve the Monitoring & Analytics and Therapeutic Care (MA & TC) complaint handling operations by providing feedback on the compliance of medical device product complaint records and supporting revisions to procedures, work instructions and training materials.
You are responsible for
- Retrieve medical device product complaint records. Promptly and accurately review them to determine compliance with minimum requirements established within company procedures.
- Maintain records of reviews per established procedures.
- Maintain confidentiality of information evaluated during record reviews.
- Report on process metrics relating to the quality of complaint records.
- Maintain professional communications with internal and external customers.
- Maintain procedures, work instructions and training materials.
- Identify and escalate quality issues.
- Support and participate in internal and external audit-related activities.
- Maintain training compliance by completing mandatory training by established due dates.
- Adhere to departmental processes to ensure regulatory compliance.
- Contributes to the completion of project tasks as assigned.
- Perform other duties as assigned by manager and functional department management.
You are a part of
An organization that believes-what you do every day can contribute to the innovative health technologies and solutions we develop that make a positive impact on billions of people every year. Including you. Because you will find when you work at Philips that your professional and personal lives often intersect in unexpected and fulfilling ways. It is our mission to improve people’s lives through meaningful innovation and we want you to play a central role in this by leading teams, driving projects, thinking strategically and inspiring colleagues from all over the world.
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree.
- 1+ years’ experience in a medical device or other regulated environments including knowledge of post market surveillance complaint handling is preferred.
- Familiar with global regulatory requirements for complaint handling and associated regulatory reporting.
- Excellent customer service and interpersonal communication skills.
- Good analytical skills and process improvement capabilities with the ability to resolve issues in creative and effective ways.
- Good written and oral communication skills.