Philips Biological Science Job Opening – Complaint Specialist Post
Looking at the challenges the world is facing today Philips’ purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you’ll be working towards creating a better and fairer future for all.
Job Title: Complaint Specialist
Location: United States of America – Home Based
Eligibility Criteria:
- Associates Degree Bachelor’s degree in Biomedical Engineering, Engineering discipline or other Biological Sciences, Healthcare preferred
- 2+ years direct experience in Complaint Handling and Vigilance Reporting role
- Experience in a Medical Device, Pharmaceutical, Biopharmaceutical or Regulated industry Knowledge of Regulatory Requirements and Standards such as 21 CFR Parts 820, 803, 806; ISO 13485, ISO9001
In this role, you have the opportunity to make life better
This individual will work with a variety of diverse disciplines within the company such as Engineers, Scientists, Clinical Specialists, Field services, Application Engineers, and Global Markets to facilitate the complaint handling process.
You are responsible for
- Review customer feedback, service records, and other sources of customer sentiment for possible complaints.
- Initiate complaint in applicable tool.
- Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint.
- Communicate with customers, call center reps, market managers to gather more data on complaints as needed.
- Confirm complaint condition and determine necessary action (including CAPA as needed).
- Assess if the Risk assessment is covering the hazard in the complaint. Complete all needed records in a timely and accurate manner.
- Evaluates, investigates, executes returns failure analysis, and resolves complaints.
Completes initial safety assessment for reportability and ensures on-time MDR submission per reporting timeline. - Analyzes complaint data, gathers additional data as needed, and partners cross-functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects.
- Applies company policies and procedures to resolve a variety of issues.
Helps ensure processes are adequately established and maintained to meet business and quality requirements related to product assessments. - Review, revise and release procedures as required Determines relevant data needed and executes the analysis, and presents insights gained.
- Improve data analysis and output.
- Support Audits as applicable.
Philips Biological Science Job
