Senior Design Quality Engineer

Job Details: Senior Design Quality Engineer

Full details of the job.

Job Requisition Name: Senior Design Quality Engineer

Job Requisition No: VN8296

Work Location: UK - Bidford

Worker Basis: Full Time

Worker Type: Employee

Applications Close Date: Not specified

Purpose

The Global Sr. Design Quality Assurance will be a multi-site leader overseeing engineering support for new product development and lifecycle management projects. This position supports a global deployment of Design Controls procedures, ensuring projects and products are safe, effective, and meet regulatory standards (FDA 21 CFR part 820, ISO 13485, MDR) from concept to commercialization. The role involves collaboration with various departments including R&D, Regulatory, Marketing, Supply Chain, and Manufacturing Operations. It also supports other aspects of the QMS, such as Quality Systems, Post Market Surveillance, and Supplier Quality.

Key Responsibilities

• Lead design quality efforts on new product development and sustaining projects with cross-functional teams.
• Support EU MDR remediation efforts.
• Manage risk planning, FMEA, risk control, mitigation, and verification of effectiveness.
• Handle quality design transfer activities, including test method validation, measurement systems analysis, and incoming inspection.
• Develop and release engineering design documentation, support design reviews, and maintain design history files.
• Provide quality input into product user needs, design inputs, specifications, and outputs.
• Support design verification and validation testing, including usability testing.
• Assist in regulatory submissions and defend design control elements during audits, leading gap assessments.
• Identify and implement process improvements through cross-functional collaboration.
• Maintain positive relationships to promote a quality culture and drive quality as a competitive advantage.
• Guide technical strategies and resolve technical issues cross-functionally.
• Support other QMS aspects, including Quality Systems, Post Market Surveillance, and Supplier Quality.

Qualifications

• Deep knowledge of FDA, ISO, MDD/MDR, and medical device industry quality requirements related to product development and risk management.
• Understanding of US and international regulations including 21 CFR 820, 803, 50, 11, EN ISO 13485, EN ISO 14971, IEC 60601, EN 62366.
• Strong communication and presentation skills.
• Proficiency in Microsoft Office and Minitab or equivalent statistical software.
• Minimum 5 years of medical device engineering experience.
• BSc in Mechanical, Electrical, or Biomedical Engineering.

Company

BVI is refocusing the future of vision. As a leading surgical ophthalmic company, our trusted brands include Beaver, Visitec, Malosa, Vitreq, and PhysIOL, operating in over 90 countries. We aim to improve lives affected by eye conditions through innovative solutions, empowering our team to make decisions and solve problems. We value agility, simplicity, transparency, and collaboration. Learn more at