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High-Tech Quality Engineering Manager
2 weeks ago
About the Position
Our organization is seeking an experienced Senior Quality Assurance Engineer to lead projects and provide design quality leadership in ensuring project deliverables comply with all internal and regulatory requirements.
Key Responsibilities
- Lead and coordinate activities related to design control, risk management, design change, and standards compliance.
- Provide technical and quality systems input to R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams.
- Draw conclusions and make decisions from test data using excellent analytical and problem-solving abilities.
- Ensure and maintain regulatory compliance with company SOPs/WIs and EU/FDA/Global guidelines.
- Support internal and external regulatory audits as required.
Requirements
- Minimum 6 years industry experience; Design Assurance experience is a plus.
- Experience in areas such as design control, risk management, design change, and standards compliance.
- Strong leadership, problem-solving, technical capabilities, communication, and collaboration skills.
- Proven ability to work well both individually and as part of a team.
About Us
We are dedicated to advancing science for life by transforming lives through innovative medical solutions that improve patient lives.
