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 in Post Market Surveillance activities: provide data.
• Participate in 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, preferably 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.
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