Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Develops and maintains the effectiveness of local QMS in accordance with the company objectives and applicable requirements

Key Activities & Accountabilities

• Develops and maintains the effectiveness of local QMS in accordance with the company objectives and applicable requirements
• Maintains, develops and/or revises QMS process documentation aligned with ISO 13485:2016 standard to incorporate appropriate regulatory and EEMEA requirements
• Ensures EEMEA procedure and document changes are reviewed and implemented where appropriate into the local QMS
• Executes QA activities in line with defined procedures and processes
• Performs scheduled internal audits of local processes, ensuring evidence of corrective and preventive actions taken is recorded and reviewed. Works with process owners to ensure timely CAPA investigation and closure.
• Ensures that all suppliers used by the organisation are selected, evaluated and re-evaluated and that records of this assessment are maintained.
• Ensures quality records are established and maintained to provide evidence of the QMS effectiveness. Monitors the quality records and data and ensures Management is informed in a timely manner of changes / trends that could affect Stryker's QMS.
• Ensures that individual actions and team processes maintain an exemplary record of compliance and commitment to the ISO 13485:2016 quality standard through the use of local QMS. Promotes a culture of quality in team behavior and by implementing continuous process improvements.
• Performs based on established targets, KPIs and objectives for RAQA.
• Provides support to EMEA / RAQA teams as appropriate.

• Fluent in English
• Qualified as QMS Internal Auditor (ISO 13485 medical devices preferred)
• Experience in a medical device quality role and understanding of EU medical device regulation preferred
• High attention to detail and process consciousness, proactive mindset
• Versatility, flexibility and willingness to work with changing priorities
• Ability to work in a rapidly changing environment, to handle multiple project and meet deadlines
• Strong communication and team working skills, ability to communicate effectively with the team and management
• Ability to prioritise and organise own workload, seeks out diverse ideas, opinions, and insights, and applies them in the workplace
• Embrace working with different geographical cultures, connects and relates well with people who think and act differently than oneself
• Project management and time management skills
• Embraces scrutiny and accepts feedback as opportunity to learn and improve
• Strong IT skills, including Microsoft Office.