Complaint Engineer - 6 months TEMP contract

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Client:

LHH

Location:

-

Job Reference:

94821d54f9e6

Job Views:

3

Posted:

21.02.2025

Expiry Date:

07.04.2025

Job Description:

For one of our clients, a medical device manufacturer based in Le Locle, we are looking for a Complaint Engineer for a 6 months TEMP contract.

Your Responsibilities:

1. Manage complaint investigation: communication with intake service, decontamination process, complaint investigation (analysis in laboratory, dimensional analysis, physical-chemical analysis, and any other necessary tests for product investigation and cause identification), review risk files, identify root cause, DHR review, report writing, archiving, escalation to NC or CAPA when applicable.
2. Implement and improve procedures related to complaints in accordance with applicable regulations/standards/requirements.
3. Track Corrective/Preventive/Improvement Actions.
4. Participate in projects related to complaints activities.
5. Raise awareness among other departments on complaints processing.
6. Apply procedures related to complaints and material vigilance.
7. Ensure adequate investigation of the complaints with relevant stakeholders (production, engineering, PD, QE, etc.).
8. Review, approve and close complaint investigations.
9. Implementation and management of complaints procedures, investigation, trending, and product surveillance.
10. Perform and review complaint trend analysis according to relevant GSOPs.
11. Management of Health Hazard Evaluation: complete documentation in coordination with relevant stakeholders (Design Quality Assurance, Medical Safety, Product Development, Post Market Surveillance).
12. Participate in Post Market Surveillance activities: provide data.
13. Participate in risk management analysis activities according to procedures and within the defined timeline.
14. Participate and support internal audits and third party audits/inspections.

Your Profile:

1. Minimum of Bachelor's Degree is required, preferably in quality assurance, Engineering, a Life Science, or a related technical discipline.
2. Minimum of 2 years of professional work experience within a quality assurance or compliance audit environment is required.
3. Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR 2017/745, 21 CFR part 820, Chinese, Canadian, Japanese, Australian, Brazilian regulations, etc.
4. Experience in a Medical Device manufacturing environment is preferred.
5. Teamwork ability.
6. Ability to interface with internal and external customers.