Senior Design QA Engineer

Are you passionate about design quality and looking for a new challenge? Join our client as Senior Design QA Engineer and help ensure top-tier standards every day.

Proclinical is seeking a Senior Engineer, QA Design Assurance to lead and oversee design control and risk management activities for combination products. This role focuses on ensuring compliance with global quality management systems and regulatory standards. You will collaborate across departments, support product development, and contribute to quality system improvements.

Responsibilities:

• Develop and implement design control processes for combination products.
• Ensure compliant design control and risk management activities.
• Oversee documentation related to design control, including MDF-DHF reviews, revisions, and approvals.
• Participate in risk assessments, execute mitigation plans, and conduct formal risk reviews in collaboration with relevant teams.
• Provide QA support to the Product Development team and train staff in design control and risk management practices.
• Assist in quality management system (QMS) control-related activities, including procedure development, review, and implementation.
• Perform change control design and risk assessments.
• Lead or participate in internal and external audits, acting as a subject matter expert in device design control.
• Collaborate on electronic GxP system implementation and training.

Key Skills and Requirements:

• Bachelor's degree in science or engineering; a master's degree is preferred.
• Solid experience in quality assurance within the medical device industry, particularly in design quality.
• Familiarity with ISO 13485, 21 CFR Part 4, 21 CFR Part 820, and MDR regulations.
• Knowledge of ICH Q8, Q9, and Q10 guidelines.
• Experience in QMS implementation for medical devices or combination products.
• Strong understanding of quality processes, including CAPA and non-conformity management.
• Proficiency in English (spoken and written) and project scheduling tools like Microsoft Project.
• Behavioral skills such as curiosity, courage, collaboration, and credibility.
  

If you are having difficulty in applying or if you have any questions, please contact Ingrid Wilson at i.wilson@proclinical.com.

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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