- Participate in and provide quality support in problem solving efforts to identify and resolve quality issues to ensure production of safe and effective medical devices.
- Lead and work with teams to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.
- Recommend, plan and lead corrective and preventive actions for continuous improvements including investigations and root cause analysis.
- Generate quality reports, evaluate and trend quality data, and propose solutions to drive process improvements.
- Drive and monitor change management process to ensure thorough completion of all changes resulting in timely closure of change requests.
- Reviews and approves validation protocols, reports, and data related to software, equipment, process, and product validations.
- Provide guidance in the proper application of statistical analysis and scientific design of all verification and validation test documentation.
- Responsible for the Site Validation Master Plan.
- Perform revalidation and risk assessments to support the site validation master plan.
- Administrator of CAPA review board for the site.
- Participate in or lead cross-functional project teams in identifying and executing programs/tactics to improve existing operations with respect to quality, cost, and delivery.
General Quality Support:
- Facilitate risk management activities including creating and maintaining risk plans, reports, and failure mode analyses for multiple product lines.
- Create, revise and approve documents as required by changes to policies or in response to compliance issues ensuring adherence to regulatory, regional and internal requirements.
- Plan and execute internal audits at the site against applicable Quality System standards/regulations and internal requirements.
- Review and approve nonconforming reports and CAPA plans
Scope of Position:
Functions independently with minimal direction and as part of a team at the Wilmington Manufacturing site.
This position must be able to liaison with several internal functional areas including Manufacturing, Engineering, Facilities, Quality Control, Customer Fulfillment, and Purchasing.
Effectively interact with external auditors, suppliers, customers and all other employees including corporate officers.