Senior Quality Engineer
Responsibilities:
- Provide QA technical and compliance expertise to establish and assure system and product quality objectives.
- Ensure compliance with applicable regulations, policies, and procedures.
- Lead quality activities such as audits, procedure development, product release, and documentation review.
- Define changes to controlled documents and provide technical and compliance support for products and manufacturing.
- Support supplier activities, corrective and preventive actions, product/process improvements, and training.
- Lead and/or facilitate compliance and improvement activities for the Neuravi quality system (e.g., CAPA, audit programs, training).
- Monitor compliance with Neuravi policies, procedures, and regulatory requirements, implementing process and system improvements.
- Conduct quality system audits, including planning, execution, reporting, and follow-up.
- Assist with risk management activities and create or recommend quality tools for business situations.
- 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.
#LI-MS2