One of our leading high-tech/medical device clients in Eindhoven has an opening for a Complaint Specialist in Eindhoven. We are looking for a Dutch-speaking professional with Medical Device industry experience and knowledge of the regulations/quality/standards.
Evaluate and resolve complaints, initiate CAPAs, analyse complaint data, other additional data as needed. Provide feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations.
- 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
- Evaluate customer feedback, service records, and other sources of customer and internal for possible complaint.
- Initiate complaint in process and applicable tool.
- Evaluate incoming data and determine if it is sufficient to understand the nature of the complaint
- Communicate with customers, call centre reps and FSEs to gather more data on complaints as needed
- Assess if the Risk assessment is covering the hazard in the complaint
- Complete all needed records in a timely and accurate manner
- Confirm complaint condition and determine corrective action (including CAPA as needed)
- Communicate as needed to follow up on and resolve complaint; follow up with end user/customer via complaint submitter when needed
- Bachelor’s degree in biomedical, engineering, healthcare, nursing or related technical degree with 4 - 8 years of experience; OR bachelor’s degree with 4+ years of experience in a medical device or regulated industry.
- Medical Device or biomedical experience in undergraduate program or other related work experience; supervisory experience
- Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
- speaking Dutch is mandatory
PROJECT START DATE
Until end of year
If you are interested in the above description, please apply with your CV and a letter of motivation by clicking on the ‘apply’ button below.
PS: Did you also know that we offer a generous referral scheme, because great people know other great people, right?
For further information, please contact Ralph Looijen at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org