Quality System Specialist

Description:

The Quality Systems Specialist will work as part our quality assurance and compliance team, supporting core quality management activities across the business to maintain compliance to medical device product development and manufacturing standards.

You will play a key role in ensuring our ISO 13485 quality management system is established, implemented, maintained, monitored, and continuously improved. This includes having responsibility for specific processes, procedures and protocols required for the design, development, and production of Osler’s medical device products.

This role will have responsibilities including creation and quality review of QMS documentation, ownership of projects driving continuous improvement, management and participation in audits and investigations, monitoring of key QMS performance indicators. You will also develop subject matter expertise in management of our electronic QMS.

The Quality Systems Specialist will provide expert guidance and support to ensure processes, procedure and protocols are effective, compliant and user friendly and will work closely with the stakeholders throughout the Osler team to ensure this.

Osler is committed to quality and as part of our growing Quality Assurance team, you will play a key role in driving and developing our quality culture, helping people to understand what is needed, why and how best to achieve it through exceptional quality management.

This is a great opportunity to work in a new company with lots of potential to shape the QMS and quality culture.

Main responsibilities:

• Manage and coordinate document control and training activities via the electronic QMS (eQMS).
• Contribute to the creation and preparation of documentation; Manage the review and approval of documents, including SOPs, WIs and to ensure compliance to Good Documentation Practices, regulatory standards, and Osler's operating requirements.
• Provide support to users of the eQMS, assisting with initiating change requests and uploading associated documentation.
• Support the delivery of the Internal Audits, Non-conformance and CAPA management system in the business.
• Coordinate, review and approve change requests.
• Identify and own opportunities for continuous improvement across the Quality Management System.
• Perform QMS Gap Analysis resulting from changes in regulations and standards and continually monitor our internal procedures, processes and SOPs to ensure appropriate reviews and approvals have taken place.
• Prepare monthly quality key performance indicators.
• Being a quality ambassador throughout Osler.
• Working as part of a multidisciplinary team.
• Supporting extension to ISO Scope to include manufacturing of medical devices.
• Supporting notified body and external audits.

Essential

Skills & Experience

• Experience of working in a quality assurance role within FDA and EU regulated QMS frameworks for medical device design, development, and manufacture, specificallISO 13485 and / or ISO 9001.
• Exceptional verbal and written communication in English, able to clearly articulate and translate quality requirements to multidisciplinary teams.
• Be enthusiastic, positive, confident in communication.
• Excellent at translating standards into best practice.
• Have a pragmatic, flexible, solutions-oriented approach.