Senior Consultant at Mason Alexander - Medtech Contract
Overview
The Snr. Quality Systems Engineer will provide expertise on managing Quality System processes and related activities as per applicable requirements. The Associate also ensures an adequate level of controls/governance on the training process related to Quality system elements. Through proactive communication across the organization, effective problem solving, and active vigilance on applicable requirements, the Associate drives compliance and effectiveness for QMS processes. The Associate ensures regular reporting through key performance metrics to the Site Quality Manager.
For assigned responsibilities, success is measured in terms of capacity to monitor compliance and effectiveness. The Associate is also expected to develop and participate in the deployment of approved Quality Plans across the organization to support defined QMS strategy and related objectives.
Main Responsibilities
* Actively engage for implementation of the Quality Management System throughout the site, targeting ISO13485 / MDSAP certification.
* Maintain the Quality Manual and Quality Procedures and ensure content is compliant with applicable requirements and helps to maintain business agility.
* Lead change control activities within the site.
* Analyse current and future procedural needs of the QMS.
* Organise and manage the plant internal audit system and the corrective action reporting system.
* Conduct Quality Systems audits and assist in training/guidance to other auditors.
* Host external/internal Quality System audits.
* Provide training on Quality best practices and QMS processes.
* Coordinate the review of Quality procedures associated with plant continuous improvement initiatives.
* Develop quality training program as per site needs.
* Coordinate quality data consolidation and reporting on Key Performance Indicators (KPIs) in order to drive continuous improvement across QMS.
* Analyse current and future procedural needs of the business.
* Plan Standard Operating practices required under the overriding Quality procedures.
* Maintain the Standard Operating Procedure content and coordinate the issuing of these documents.
* Support other functional areas of the business including engineering, design, etc.
* Collate quality data for monitoring targets.
* Assist with training of quality awareness.
* Report on Key Performance Indicators (KPIs) in order to adhere to process and prevent the occurrence of any non-conformity relating to product, process, or system.
* Promote the use of customer preferred techniques for continuous improvement such as Six-Sigma, Poka-Yoke (Error Proofing), and Measurement System Analysis.
* Keep up with current and developing design and engineering trends that concern product quality.
* Undertake special projects as required.
* Contribute to continuous improvement activities.
* Plan projects or sub-tasks so they may be tracked and presented.
* Attend various meetings and action/communicate instructions.
* Undertake continuous training and development.
* Perform root cause analysis and resolve problems.
* Independently determine approach and assigned tasks.
Qualifications
- Requires a minimum of a technical degree in science or engineering, with a minimum of 5 years of relevant experience in the medical device industry. A strong knowledge of worldwide applicable regulations for Quality systems (ISO13485, 21CFR820).
- The ability to collect data, analyze situations, and propose optimal process solutions to meet both Compliance and Business requirements.
- An individual in this role must have proven leadership, communication, organization, and project management skills with a strong orientation on processes.
- The ability to communicate efficiently in an international environment with internal/external customers and key stakeholders.
- A strong working knowledge of managing life cycle documents and records. Deep understanding of change control and training process requirements.
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