Senior Quality Engineer
This role is responsible for providing technical and compliance expertise to ensure system and product quality objectives are met.
Responsibilities:
1. Provide QA technical and compliance expertise to establish and assure system and product quality objectives.
2. Ensure compliance with applicable regulations, policies, and procedures.
3. Lead quality activities such as audits, procedure development, product release, and documentation review.
4. Define changes to controlled documents and provide technical and compliance support for products and manufacturing.
5. Support supplier activities, corrective and preventive actions, product/process improvements, and training.
6. Lead and/or facilitate compliance and improvement activities for the Neuravi quality system (e.g., CAPA, audit programs, training).
7. Monitor compliance with Neuravi policies, procedures, and regulatory requirements, implementing process and system improvements.
8. Conduct quality system audits, including planning, execution, reporting, and follow-up.
9. Assist with risk management activities and create or recommend quality tools for business situations.
10. Perform other duties as assigned.
Requirements:
* Minimum Bachelor's Degree in Engineering, Science, or a related technical field.
* At least 5 years of QA, Quality System, or regulatory experience in the medical industry.
* Auditor certification from an industry-recognized organization is beneficial.
* Knowledge of FDA's 21 CFR Part 820, ISO 13485:2016, European Medical Device Directive, and Canadian Medical Device Regulations.
* Experience in preparation for notified body and FDA inspections.
* Experience with QA activities in a manufacturing environment, including project management skills and leadership ability.