Responsabilities • 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 Bachelors 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 jid36484eba jit0417a jiy25a