Quality Assurance Specialist
6 days ago
We are seeking a highly motivated and detail-oriented Quality Systems Specialist to join our team at Q'Apel Medical Inc. This role will play a critical part in ensuring the quality and compliance of our medical devices.
Key Responsibilities:- Process Engineering Change Notices (ECOs) and other Quality Management System documentation in a timely and efficient manner.
- Review and provide feedback on ECOs for completeness and accuracy.
- Perform data entry and notification of approved ECOs and distribution of released documentation.
- Support with scanning and filing of Quality Records and other department files/logs/records.
- Assist with the implementation and enhancement of new and existing eQMS modules to improve system efficiency.
- Provide support for audits by collecting and preparing process and procedural audit data.
- Help to resolve documentation-related issues.
- Drive continuous system, process, and product improvements throughout the organization.
- Support Nonconformance Control and CAPA activities.
- Generate Document Control and Training metrics as required.
- Bachelor's degree in sciences, engineering, or a related discipline.
- 3-5 years of Quality Assurance/Doc Control experience in the medical device industry.
- Strong knowledge of ISO 13485:2016, EU MDR 2017/745, MDSAP, and ISO 14971.
- Effective communication skills and ability to present to a broad audience.
- Proficiency in Microsoft Office and Windows applications.
Competitive salary range of $60,000 to $75,000 + equity + benefits.
Opportunity to work in a fast-paced startup environment with a passionate team.
Professional growth and development opportunities.
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