This role is for a quality engineering leader who will oversee design control processes within a medical device company. It’s a crucial position ensuring devices meet regulatory requirements and function safely.

Responsibilities:

• Manage design control activities according to ISO 13485:2016 (international standard for medical device quality management).
• Handle change controls, design reviews, and maintain the Design History File (documents tracing a device’s development).
• Oversee risk management processes and ensure traceability within the company.
• Lead design verification and validation (ensuring the device design meets specifications and user needs). This includes writing protocols and reports.
• Lead investigations of design problems and implement corrective actions.
• Qualify and evaluate suppliers involved in the design and manufacturing process.
• Manage and control activities in clean rooms, ensuring proper validation and control.
• Collaborate effectively with production, engineering, and R&D teams.

Qualifications:

• Bachelor’s degree in science, mechanical/medical engineering, or a related technical field.
• Fluent English with strong writing skills.
• At least 5 years of experience in medical device quality assurance, preferably in the cardiovascular field.
• Basic understanding of manufacturing and design processes.
• Strong knowledge of relevant regulations: QSR (Quality System Regulation), ISO 13485, and MDSAP (Medical Device Single Audit Program) policies and procedures.
• Ability to work independently with minimal supervision.
• Excellent communication skills (written and verbal).
• Strong organizational skills with the ability to prioritize tasks effectively.
• Ability to manage stress and navigate conflicts while upholding regulatory principles.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
• A quality qualification (lead auditor certification) is a plus.

Overall, this QA Design Engineer plays a vital role in ensuring the quality, safety, and regulatory compliance of medical devices.