Beschreibung
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