QA Engineer MDR

Recooty; Basel; Vor Ort; CHF 90’000 - 130’000; Vollzeit

Zusammenfassung

An established industry player seeks a dynamic professional to lead their Quality Management System in compliance with MDR regulations. In this pivotal role, you will be responsible for overseeing the product registration process, conducting internal audits, and ensuring training compliance. Your expertise in Regulatory Affairs and Quality Assurance will be crucial in maintaining high standards in a world-class medical device manufacturing environment. This opportunity offers a chance to make a significant impact in a collaborative setting, where your leadership skills and commitment to ethics will be valued. If you are ready to take your career to the next level, this role is perfect for you.

Qualifikationen

• 5+ years in Regulatory Affairs, Clinical Affairs, or Quality Assurance.
• Expertise in MDR and cGMP compliance in medical device manufacturing.

Aufgaben

• Build and maintain certified MDR Quality Management System.
• Lead product registration process with Notified Body.
• Conduct internal audits and provide quality-related training.

Kenntnisse

Regulatory Affairs

Quality Assurance

Clinical Affairs

MDR Compliance

cGMP Compliance

Leadership Skills

Software Development in Medical Devices

Ethics and Integrity

Cultural Adaptability

KPI Tracking and Reporting

Ausbildung

Bachelor’s degree in Life Science

Jobbeschreibung

Responsibilities:

• Build and maintain certified MDR Quality Management System
• Lead product registration process with Notified Body
• Represent the QMS as deputy PRRC
• Maintain local training compliance
• Lead and participate in internal audits
• Provide Quality related trainings
• Organize site Management Review
• Track and report KPIs
• Supplier qualification including leading of audits
• Site QARA projects

Skills Required:

• Bachelor’s degree in Life Science or equivalent
• Minimum of 5 years’ experience in Regulatory Affairs, Clinical Affairs or Quality Assurance
• Record of success and broad understanding of contemporary quality practices as they apply to product development, manufacturing, and commercial operations
• Proven expertise in the design and implementation of quality processes in world-class medical device manufacturing organization under MDR regulation
• Expertise in MDR, cGMP and other Regulatory compliance requirements
• Experience in software development in the medical device context
• Self-confidence and the ability to work with all levels of organization
• Operates in a way that never compromises ethics and integrity
• Advanced leadership skills
• Ability to understand and adapt to different cultures and market needs
• (Inter-)national travel as required by business (up to 10%)