Description:
We are seeking a highly motivated and experienced Quality Engineer to join our team in the Medical Device industry. The ideal candidate will have 4-5 years of experience in quality engineering, with a strong understanding of quality systems, regulatory requirements, and the lifecycle of medical devices. The Quality Engineer will be responsible for ensuring the highest quality standards are met throughout the design, development, and manufacturing processes, while complying with regulatory requirements such as ISO 13485, FDA regulations, and other applicable standards.
Key Responsibilities:
- Support the implementation and maintenance of QMS processes in accordance with ISO 13485 and other applicable regulatory requirements (e.g., FDA, MDSAP, CE marking).
- Assist in the development and review of quality policies and procedures to ensure compliance and continuous improvement.
- Perform internal audits and support external audits by regulatory bodies and notified bodies.
- Participate in the risk management process (e.g., FMEA, Hazard Analysis) for new product development and manufacturing processes.
- Ensure risk management documentation is in place and maintained according to ISO 14971 and relevant regulations.
- Support the design control process for new product development, including design verification, validation, and design transfer.
- Review and approve design documentation such as design specifications, protocols, and reports.
- Lead investigations into non-conformances, deviations, and customer complaints.
- Initiate, track, and close CAPA activities ensuring effective root cause analysis and corrective/preventive actions are implemented.
- Assist in process validation activities (IQ, OQ, PQ) for new and existing manufacturing processes.
- Support statistical process control (SPC) methods to ensure manufacturing processes remain in control and meet quality standards.
- Evaluate, audit, and manage supplier quality performance.
- Review and approve supplier quality documentation (e.g., Certificates of Compliance, inspection reports) and support supplier corrective actions.
- Ensure that all products meet regulatory requirements throughout the product lifecycle.
- Support submission activities to regulatory agencies (FDA, CE) for product approvals.
- Provide training to team members on quality system processes, regulatory requirements, and quality tools.
- Collaborate with cross-functional teams (e.g., R&D, Manufacturing, Regulatory) to ensure quality is integrated into all stages of product development and production.
- Actively participate in and drive continuous improvement initiatives within the quality system and manufacturing processes.
- Use tools such as Lean, Six Sigma, and root cause analysis to identify and resolve quality issues.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 4-5 years of experience in quality engineering in the medical device industry.
- ASQ CQE, Six Sigma Green/Black Belt, or similar certifications preferred.
- Strong knowledge of medical device regulations (FDA, ISO 13485, ISO 14971).
- Proficiency with quality tools (CAPA, FMEA, root cause analysis, statistical process control, etc.).
- Experience with FDA submissions and design control processes.
- Familiarity with ERP, QMS, and data analysis tools (e.g., Minitab, JMP).