The successful PMS and Corrective Action Manager will be responsible for monitoring, understanding and managing product quality customer complaints received by the company. He/She will also manage Global Field Actions and will oversee a team to manage activities ensuring Senior management are informed as required on relevant issues.
- Management of company complaint handling, vigilance reporting and field safety corrective action systems and ensuring same is compliant with current regulations.
- Development and provision of a harmonized complaint reporting and management system in International including:
- Streamline complaint handling & vigilance processes across International.
- Support implementation of an integrated complaint management IT system across International.
- Development of complaint & vigilance metrics to International Senior Management.
- Root cause analysis improvement and standardization of complaint investigation reports across manufacturing sites.
- Coordinate complaint follow-up and completion of appropriate corrective actions.
- Manage the coordination of Global Field Safety Corrective Actions.
- Support for the risk management process, provision of complaint data to risk management process to allow the files to be maintained as current.
- Maintain close working relationships with Regulators and Notified Bodies Globally.
- Managerial responsibility for Post Market Surveillance personnel. Development of direct report KPIs and goals and objectives and the regular review of same.
- Support the expansion and enhancement of post-market surveillance activities as it develops.
- Maintain close working relationships with complaint handling and vigilance group in US headquarters.
Essential Skills / Experience
- Engineering/Science qualification with 5 years of working within complaints in a medical device environment.
- Proven experience as an effective Post Market Surveillance & Field Corrective Action Senior Manager in the Medical Device Industry.
- Excellent technical writing experience within a medical device environment – essential.
- Knowledge of Quality and Regulatory requirements and regulations.
- Attention to detail and accuracy – essential
- Ability to work well under deadlines and pressure
- Problem solving skills for developing creative solutions and meeting objectives are required.
Full spec on request
For more information or to apply please contact Tina Egan on firstname.lastname@example.org 09064 78104.
Please Note: Collins McNicholas will not forward your details to any company without your prior approval.
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