- 11 oktober 2018
- vacaturenummer: 86787
Complaint Handling Specialist MCC
Evaluate incoming complaint data and determine if it is sufficient to understand the nature of the complaint. Gathers additional data as needed.
Initiates necessary containment.
Analyzes complaint data and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and teams on potential product manufacturing teams on potential defects, and safety evaluations.
Completes all needed records in a timely and accurate manner
Keys areas of responsibilities:
-Work with a variety of diverse persons within the company such as Engineers, Scientists, Clinical Specialists, Field Service & Application Engineers, and Manufacturing personnel to facilitate the complaint handling process globally.
Engineers, and Manufacturing personnel to facilitate the complaint handling
Communicate with complaint submitters to gather more data on complaints as needed, to follow up on and resolve complaint.
Quality minded, accurate.
Ability to work under pressure, ability to prioritize.
Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules
Works on issues where analysis of situation or data requires review of relevant factors.
Exercises judgment within defined procedures and policies to determine appropriate action.
Serves as individual contributor, working to meet schedules and resolve problems.
Education/ Experience & Background:
1+ years of experience in a medical device or regulated industry.
Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, 21 CFR Parts 803, 806, and 820,
ISO13485, and ISO9001.
Fluent in English, verbal and written is a must have
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.