Responsibilities
Management of the complaint technicians’ team: Organize necessary resources to support activities. Ensure that goals and objectives are set and followed for every team member in accordance with the company’s G&O’s.
Ensure polyvalence of the team
Review and close complaint investigations for Le Locle
Implementation and management of complaints procedures, investigation, trending, and product surveillance
Ensures that Quality indicators (ex. Complaint, trends, etc.) are established and communicated
Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with others teams members (Design Quality Assurance, Medical Safety, Product Development, Post market Surveillance) to complete the required documentation
Perform complaint trend analysis according to Integra GSOP: complete an investigation when necessary
Participate to Post Market Surveillance activities: provide data
Participate to risk analysis activities according to procedures and within the defined timeline
Participate and support internal audits and third party audits / inspections
Ensure that adequate Quality support is provided to production and to open projects / initiatives
Ensure that Nonconformances are initiated, dispositioned, approved and investigated according to plans and in compliance with procedures and regulatory requirements
Ensures that GMP rules are known, understood and respected on the site
Escalates quality issues and makes sure that appropriate actions are in place to fix the issue in a compliant manner
Qualifications
A minimum of a Bachelor's Degree is required, preferable in quality assurance, Engineering, a Life Science or a related technical discipline.
Minimum of 5 years of professional work experience within a quality assurance or compliance audit environment is required.
Experience in a Medical Device manufacturing environment is preferred.
Fluent in French and English
Knowledge of Medical device standards and regulations such as ISO13485, 93/42 EEC MDD, EUMDR, 21 CFR part 820, Canadian, Japanese, Australian, Brazilian regulations, etc.
Strong management skills
Strong communication, organizational, negotiation and interpersonal skills
Strong analytical problem-solving skills.
The ability to collaborate with all levels of management across multiple sites and functions
Ability to interface with internal and external customers
Use of Agile, Oracle, EtQ, Minitab, Trackwise
Use of Microsoft office tools
Knowledge of statistical techniques
#J-18808-Ljbffr