QA Specialist (2-Year Fixed-Term Contract)

Supports the effectiveness and compliance of the local Quality Management System by maintaining QMS processes managing quality records CAPAs supplier quality activities and driving continuous improvement in accordance with ISO 13485 and medical device regulatory requirements.

What you will do

• Maintain and continuously improve the local Quality Management System (QMS) in accordance with ISO 13485:2016 company objectives and applicable regulatory requirements.
• Develop revise and maintain local QMS procedures work instructions and related documentation.
• Ensure EEMEA quality procedures and document updates are reviewed and appropriately implemented locally.
• Execute quality assurance activities in compliance with established procedures and processes.
• Manage nonconformities (NCs) and corrective and preventive actions (CAPAs) ensuring timely investigation implementation and closure with process owners.
• Support supplier qualification evaluation and re-evaluation activities maintaining appropriate records.
• Ensure quality records are established maintained and monitored to demonstrate QMS effectiveness.
• Analyze quality data and trends promptly informing management of issues that may impact the effectiveness of the QMS.
• Promote a strong culture of quality compliance and continuous improvement throughout the organization.
• Deliver performance against established RAQA goals KPIs and objectives.
• Provide support to EMEA and broader RAQA teams as required.

What you will need

Education

• Bachelors degree (BSc) in a relevant field.

Experience

• Experience in the medical device industry preferred.

Knowledge Skills & Competencies

• Fluent in English.
• Understanding of ISO 13485 and preferably EU Medical Device Regulation (MDR).
• Strong attention to detail and process-oriented mindset.
• Proactive adaptable and capable of managing changing priorities.
• Ability to work effectively in a fast-paced environment and manage multiple tasks simultaneously.
• Strong communication collaboration and stakeholder management skills.
• Effective planning prioritization and organizational skills.
• Open to diverse perspectives and able to work effectively across different cultures and geographies.
• Receptive to feedback and committed to continuous learning and improvement.
• Proficient in Microsoft Office applications.

Romania Pay Ranges:

• Romania: L8.300 - L13.800 RON Monthly

At Stryker we believe transparency helps candidates make confident decisions about their next career step. Compensation is an important part of that process and we want to be clear about how pay is determined. The compensation information posted for this role may be presented as a salary range or a fixed amount depending on the addition to base salary this role may be eligible for incentive compensation (such as bonus and/or commissions where applicable) along with Strykers comprehensive benefits package.

If youd like to learn more about the salary or the benefits associated with this role your recruiter will be happy to walk you through the details as you progress through the hiring process.