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.
* Ensure that Quality indicators (ex. Complaint, trends, etc.) are established and communicated.
* Manage Health Hazard Evaluation when necessary: prepare the documentation and coordinate with other team 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.
* Ensure that GMP rules are known, understood, and respected on the site.
* Escalate quality issues and ensure 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 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.
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