Quality Assurance Specialist - Medical Device

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

Position Summary

Develops and applies intermediate knowledge and understanding of the RA (Regulatory Affairs) frameworks, legislative requirements, processes and procedures in the EMEA distribution organization.

Key Activities & Accountabilities

• Executes RA activities in line with defined procedures and processes.
• Collects, organises and maintains files on local, regional, and global RAQA intelligence.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation
• Identifies opportunities for continuous improvement and supports those activities across RAQA.
• Performs based on established targets, KPIs and objectives for RAQA.
• Provides support to EMEA / Country teams as appropriate.

Education

BSc degree in relevant field.

Experience

1-2 years' experience.

Knowledge/Competencies

• Project management and time management skills, writing, coordination, and execution of more complex RA items.
• Coordinate and support and lead technical and scientific RA activities.
• With minimal supervision, performs work that is varied and that may be somewhat difficult in character, conferring with superiors on unusual matters.
• Undertaking assignments that are broad in nature, requiring originality and ingenuity
• Ability to take limited unreviewed action or decisions
• Clearly conveys information to peers, supervisors, and other stakeholders across the EMEA organization, Design Divisions and third-party distributors.
• Prepares for meetings with regulatory agencies, internal and external audits and other stakeholders, with minimal support.
• Assists in the preparation of briefings and other information documents.
• Communicates information and advises on RA requirements to other departments and business units.
• Engages in communication with regulators and other key stakeholders on routine and complex matters with minimal supervision.
• Creates clarity and direction amid complexity and develops solutions for self, colleagues, and the organization.
• Seeks out diverse ideas, opinions, and insights, and applies them in the workplace.
• Connects and relates well with people who think and act differently than oneself.
• Embraces scrutiny and accepts feedback as opportunity to learn and improve.
• Preparation of RA / QA / PMS metrics for reporting purposes.
• High attention to detail and process consciousness.
• Strong IT skills, including Microsoft Office.
• Fluent in English and Turkish language

About Stryker

Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com