What are the responsibilities and job description for the Quality Engineer position at BioTalent?
We are seeking a Quality Engineer to join our team and ensure compliance with medical device regulations and industry standards. The ideal candidate will have 1-3 years of experience in quality engineering within the medical device sector and be well-versed in quality management systems, regulatory requirements, and continuous improvement initiatives.
Key Responsibilities :
- Support the implementation and maintenance of Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, MDR, and other applicable regulations.
- Conduct root cause analysis and corrective / preventive actions (CAPA) to resolve quality issues.
- Participate in internal and external audits, ensuring compliance with regulatory and company requirements.
- Assist in the development and review of design verification and validation (V&V) protocols for new and existing medical devices.
- Support risk management activities, including FMEA (Failure Modes and Effects Analysis) and risk assessments.
- Work with cross-functional teams to support supplier quality management, including audits and corrective actions.
- Review and approve engineering change orders (ECOs), deviations, and non-conformance reports.
- Ensure process validation (IQ, OQ, PQ) is conducted per regulatory and company standards.
- Maintain and improve documentation control processes within the QMS.
- Support continuous improvement initiatives to enhance product quality and manufacturing processes.
Qualifications & Requirements :
