complaint engineer.

• 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

• Implement and improve procedures related to complaints in accordance with applicable regulations/standards/requirements

• Track Corrective/Preventive/Improvement Actions

• Participate to projects related to complaints activities

• Raise awareness among other departments on complaints processing

• Track indicators

• Apply procedures related to complaints and material vigilance.

• Ensure adequate investigation of the complaints with relevant stakeholders (production, engineering, PD, QE, etc.)

• Review, approve and close complaint investigations for Le Locle

• Implementation and management of complaints procedures, investigation, trending, and product surveillance

• Perform et review complaint trend analysis according to relevant GSOPs

• Management of Health Hazard Evaluation: complete documentation in coordination with relevant stakeholders (Design Quality Assurance, Medical Safety, Product Development,

• Post market Surveillance)

• Participate to Post Market Surveillance activities : provide data

• Participate to risk management analysis activities according to procedures and within the defined timeline

• Participate and support internal audits and third party audits / inspections

Your profile:

• Minimum of Bachelors Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.

• Minimum of 2 years of professional work experience within a quality assurance or compliance audit environment is required.

• 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.

• Experience in a Medical Device manufacturing environment is preferred. 

• Training in laboratory techniques in medical

• Teamwork ability

• Ability to interface with internal and external customers

• Communication, organizational, negotiation and interpersonal skills

• Risk management knowledge

• Root cause analysis methods

• Fluent in English and French

• Use of Microsoft office tools