Senior Quality Specialist

Reporting to the Quality Manager, the Quality Assurance Specialist will support the implementation of Quality at Third Party sites and working cross-functionally to develop, implement and train on procedures, processes and work instructions.

You will be involved in all aspects of the day-to-day QA oversight providing support internally and for our Third-Party Sites. You will be organized and adaptable and able to work independently to support our vision.

Key Duties and Responsibilities

• Providing Quality Support to our Third-Party Sub-Contractors including hosting meetings for Material Review and process improvement workshops
• Creation of Quality documentation including Quality Agreements, SOP’s and Work Instructions
• Participate in cross-functional team meetings for process and product changes and improvements
• Leading on internal and supplier non-conformance reports, including the management of corrective and/or preventative actions (CAPA's).
• Providing support and guidance to the operational team on inspection processes, new product introductions and process improvements
• Review of Change Controls as QA representative and issuing relevant documentation to Third Part sites for implementation
• Identify and drive system improvements, both within the cross-functional department and in collaboration with third party sites, determine the most effective way to accomplish a goal or strategy; suggest improvements to maximize quality and productivity
• Providing support for internal and external audits
• Providing support for performing audits of Third-Party Suppliers
• Preparing and implementing Quality assurance policies and procedures
• Knowledge of Quality Management System elements alongside experience in maintaining and improving systems where required
• Provides input to development of corporate standards, policies and standard operating procedures (SOPs) for Information and Quality Systems
• Identifying and resolving workflow and production issues
• Ensuring that standards and safety regulations are observed
• Creating training materials and operating manuals
• Provide reports to communicate the status of open and aging quality actions
• Maintain audit readiness for all Quality Systems processes, records & reviews
• Participate in continuous improvement projects, from concept stages to implementation – taking compliance, verification, validation and risk analysis into consideration
• QA Manager delegate

Requirements

• 4+ years experience working within a Quality role
• Previous experience within software as a medical device, or Pharmaceutical
• Good understanding of start-ups and ability to adapt to various quality roles
• Previous experience in the compilation, review, and maintenance of technical documentation
• Strong attention to detail & ability to manage multiple projects
• Understanding of applicable Quality System Regulations (e.g., ISO 13485:2016 and MDSAP) quality requirements and be able to build upon them
• Ability to plan and/or oversee quality system/processes, documents, and audits/assessments
• Ability to demonstrate initiative, balance assertiveness working as a team player to assist the Quality Manager
• Understanding of MDR is a plus
• Good analytical and problem-solving skills, with great attention to detail
• Great team spirit; we're a small team you'll need to be prepared to get involved in whatever it takes to get the job done.

Benefits

• 401k contribution up to a maximum of 3% on base salary
• 70% contribution towards Health, Optical and dental plans including partner and family.
• 1 x Life & AD&D Insurance
• Holidays: 33 days per year inclusive of public holidays
• Travel expenses covered
• Employee Assistance Program
• Team events