Senior Director, Quality Systems

Salary not available. View on company website.

ConvaTec Inc, Shotton, Sir y Fflint - Flintshire

Full time
Permanent
Remote working

Posted today, 16 Oct | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

job Ref: 0242f1594d934d539f84f8fb68b9a83a

ConvaTec Inc

Full Job Description

This position is responsible for developing and maintaining a Quality Management System that is compliant, effective, efficient, and agile.
This position directly manages the Non-conformance, CAPA, Change Control, Documentation Control, and Management Controls systems and processes.
This position provides strategic and tactical guidance on establishment of quality metrics to aid in the monitoring of the health of the Quality Management System
This position develops proactive strategies that successfully execute both process improvements and program execution activities for the various Quality Management System processes.
This position is responsible for the identification and escalation (including Health Hazard Evaluations and Escalations to Market Action) of Quality Management System issues..
Manage team of Quality managers, associates, specialist and analyst in direct ownership of Non-conformance, CAPA, Stop Ship, Health Hazard Evaluation, Market Action, Change Control, Documentation Control, Quality Training and Management Controls systems and processes
Responsible for systems compliance for Documentum system (Document management), TrackWise system (QMS processes), and other e-systems to ensure that system is compliant with processes and procedures. Participate in process and system improvements as needed.
Along with direct reports, acts as the Subject Matter Expert for Non-conformance, CAPA, Stop Ship, Health Hazard Evaluation, Market Action, Change Control, Documentation Control, Quality Training and Management Controls systems and processes in all regulatory body investigations and interactions
Oversee the UDI Program and ensure that Economic Operator Standards and correct adherence is in place
Ensures appropriate systems are effective assuring the adequacy and effectiveness of CAPA investigations and related corrective and preventive actions in order to meet compliance requirements and prevent recurring non-conforming issues
Establish robust Management Review process to ensure linkages of all sites to Corporate and provide visibility to senior management
Will lead the Corporate CAPA Review Board and provide strategic direction, guidance, and facilitation of corrective actions, track completion of and determine the effectiveness & sustainability of corrective actions for CAPAs
Facilitate cross-functional reviews to monitor and improve the Quality Management Systems health
Train and mentor site owners in all required elements and best practices of Non-conformance, CAPA, Stop Ship, Health Hazard Evaluation, Market Action, Change Control, Documentation Control, Quality Training and Management Controls systems and processes.
Develops and provides leading and lagging metrics to Senior Leadership to communicate progress and risks associated with the Quality Management Systems. Ensures proper controls are in place to monitor and maintain results and continuous improvements
Together with cross functional leadership, ensuring CAPA commitments are being met and promote accountability through the entire CAPA process
Integrate the Quality Management Systems across different Business Units and acquisitions
Monitoring status and ensuring adequate resourcing of of Non-conformance, CAPA, Stop Ship, Health Hazard Evaluation, Market Action and Escalation, Change Control, Documentation Control, Quality Training and Management Controls systems and processes
Oversee Project Managers to further drive continuous quality improvement and timely completion of key initiatives
This position serves as a delegate for the person responsible for regulatory compliance (PRRC) as outlined in Article 15 of EU MDR (EU) 2017/745
May oversee quality compliance activities if needed as back-up, for external audit and internal audit processes.

Minimum Bachelor's Degree in Engineering, Life Sciences or a Technical Field
Experience in a leadership role in the medical device or healthcare industry - leading an effective quality assurance / control operation, including the management and motivation of a range of technically qualified personnel.
Knowledge of regulatory requirements that affect the medical device manufacturing business, headquarters' policies and systems in place to achieve conformance.
Knowledge of regulatory requirements that affect the medical device manufacturing business and puts policies and systems in place to achieve conformance: QSR Part 820, ISO 13485, MDD, MDR, 93/42, ISO 9001, GMP Parts 210 and 211
Project management experience in implementing processes and systems changes.
Sound understanding of technical information and the importance of its relationship to change and documentation control and their impact on a business and regulated environment.
Detailed understanding of Non-conformance, CAPA, Change Control, Documentation Control, and Management Controls requirements and strong knowledge of Quality Management Systems.
Demonstrated ability to work with other functions to develop successful business processes. Ability to negotiate and partner with internal and external customers to enhance operational effectiveness.
Ability to set priorities and deliver results without constant feedback/input from manager (required based on level of responsibility).
Proven ability to understand complex processes/problems and propose alternate solutions (required based on need to design and implement global business processes and policies, which requires critical thinking and analysis skills).
Ability to identify, manage, and/or escalate issues and risks to timelines (required based on time-sensitive nature of assignments).
Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate) from key stakeholders (required to ensure completeness and robustness of processes and ensures effective adoption of processes).
Ability to negotiate and partner with internal and external customers to enhance operational effectiveness.
Ability to work with and manage people / teams in a complex, changing environment, to deliver value-added results to the business.