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Senior Design Quality Assurance Engineer
1 month ago
We are seeking a highly skilled Senior Design Quality Assurance Engineer to join our team at Precision Neuroscience. As a key member of our Quality Team, you will play a crucial role in ensuring the development and implementation of quality processes and policies for our medical devices.
Key Responsibilities:- Develop and maintain risk management files, ensuring compliance with ISO 14971
- Provide guidance and training on risk management and design control processes
- Serve as quality representative for design and development projects
- Ensure adequate design control documentation and records are maintained
- Support new product launch, master validation plans, and design transfer into manufacturing
- Implement and review changes to existing products and processes
- Create or provide guidance on protocols and reports for various design aspects
- Support and prepare documentation for regulatory submissions
- Manage Post-Market Surveillance and Feedback into Risk Management
- Support quality system processes, including CAPAs, internal audits, and Supplier Quality
- BS or more in a relevant engineering or scientific discipline
- Minimum of 5 years' medical device industry experience, preferably with both disposable and capital equipment
- Experience in working with Class II or III devices required
- Excellent interpersonal, written, and verbal communication skills
- Knowledge of and experience in manufacturing medical devices in conformance with Quality System Regulation and ISO 13485 requirements
- Proficiency with medical device development lifecycles and manufacturing processes and technologies
- Ability to focus on and achieve scheduled milestones, including contingency planning
- Strong knowledge and understanding of FDA regulations (21 CFR 820), ISO 13485, and ISO standards related to medical device manufacturing
- Strong team-working and communication skills
Precision Neuroscience is an equal opportunity employer committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. We do not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.
