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Site Quality Lead
4 weken geleden
Job Summary:
The Site Quality Lead will lead the overall management and effectiveness of the quality management system and provides overall direction to the quality function.
The Site Quality Lead will plan, execute and manage the quality management system and activities including quality engineering, quality operations and laboratories, product release, quality systems, corrective and preventive action, non-conforming system, risk management processes, document control and training systems, ensuring compliance with regulatory and company requirements.
The Site Quality Lead serves as Management Representative for the plant and European Authorized Representative (EAR) for the Mentor Legal Manufacturer located outside the EU who places a medical device on the European markets. The Site Quality Lead has the necessary independence, authority and responsibility to maintain the plant in compliance with all applicable regulatory requirements. He/she reviews and acts as approval authority or delegated authority, retaining responsibility for all specifications, protocols, validations, fact books, and non-conformances.
Main duties and responsibilities:
- Serves as the site Management Representative as defined in the Quality System Regulation and ISO 13485. Performs the duties of Management Representative as defined in the appropriate Quality Manual and governing procedures.
- Serves as the Authorized Representative Person Responsible for Regulatory Compliance (AR PRRC) according to EU-MDR.
- Monitoring the quality management system as part of the Quality System Management Review and Quality Audit Program to ensure compliance all applicable regulations and standards.
- Reviewing performance of the process/system for the site at planned intervals to ensure suitability, adequacy, and effectiveness of the quality management system and to identify opportunities for improvement. Ensuring continuous process and product improvement.
- Ensuring the promotion of awareness of regulatory requirements throughout the organization. Communicating to the organization the importance of meeting customer, statutory, and regulatory requirements.
- Defining the purpose and objectives of the quality system in the form of the quality policy and annual quality strategic plans, which are further developed into strategic goals and objectives. Has authority and responsibility to assure the goals supporting the objectives are attained including ensuring the availability of adequate resources in consideration of the yearly manufacture volumes and other needs for the quality system. Prioritize goals to achieve deadlines and the objective.
- Monitoring key quality performance measures and corrective action results. Responsible for the CAPA system and reporting on the results to management with executive responsibility; recommending and initiating corrective and/or preventive action as appropriate.
- Overall risk management planning, including ongoing review of the effectiveness of risk management activities ensuring that policies, procedures and practices are established and documented for analyzing, evaluating and controlling product risk throughout product realization.
- Ensures the analysis, evaluation, and presentation of information concerning factors such as business situations, production capabilities, manufacturing problems, economic trends, and design and development of new products.
- Oversees the development of policies and procedures related to quality which affect operational and compliance status.
- Assures compliance with all local government regulatory requirements and requirements related to things such as sampling plans, design control, and quality systems.
- Develops initial and subsequent modifications of product assurance programs to delineate areas of responsibility, personnel requirements, and operational procedures within program.
- Evaluates contents of reports on product assurance from department heads and confers with top management personnel in preparation to formulating a fiscal budget.
- Oversees and ensures proper execution and compliance in complaint handling investigations performed by the site.
- Oversees the quality review resulting from statistical and data analyses for projects involving the design, development or validation of new or existing products and processes.
- Ensures troubleshooting and solutions to quality issues through statistical analysis and process excellence tools.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Co-approve the Declaration of Conformity, and the Change Notice to the Notified Body.
- Ensure that incidents and Field Safety Corrective Actions involving Mentor breast implants are notified to the relevant National Competent Authority when reporting criteria are met according to the current regulation/guidelines.
- In consideration of the yearly manufacture volumes and other needs for the
