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Quality System Specialist
7 months ago
Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with mínimal side effects.
If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.
**General Accountability**:
Support the Quality/Regulatory department as required in all aspects of quality control, quality assurance and regulatory compliance activities.
**Duties and Responsibilities**:
- Assist with monitoring and maintenance of the company’s Quality Management System, including all applicable procedures and instructions.
- Ensure that all employees are familiar with and follow document control procedures and good documentation practices. Perform training on these activities for new employees.
- Oversight and management of employee quality training records. Assign relevant training and follow up to completion. Maintain training matrix, training log files, electronic and hardcopy training records.
- Organize and store quality records, enabling timely retrieval when necessary.
- Participate in design and development activities as required, assist with generation and maintenance of Design History Files, and ensure DHF compliance to applicable procedures and regulations.
- Assist with transfer of new designs to manufacturing, including quality control activities from production processes to shipment of the final product.
- Assist with execution and monitoring of quality system processes such as change control, complaint management, nonconforming product handling, returned goods processing, and CAPA.
- Provide support for the supplier management program. Evaluate suppliers, monitor supplier quality issues, and coordinate failure investigations and supplier corrective action requests in a timely manner. Create reports on supplier performance.
- Assist with management of the equipment maintenance program including equipment calibration, preventive maintenance, tracking of facility maintenance and controlled environments for manufacturing.
- Perform inspection of finished devices and product device history records to ensure conformity with the quality management system and applicable regulatory requirements before a device is released. Review, maintain and archive Device History Records.
- Track data metrics such as yield/scrap rates, failure modes, and target timelines for quality processes.
- Conduct Internal Quality Audits and support the audit program as needed
- Participate in and support 3rd party audits and inspections (ISO, Notified Body, Health Canada, FDA, etc.)Stay abreast of current medical device standards and regulations and revise company documents to meet new requirements.
- Other duties as assigned.
**Education and Certification**:
- Bachelor’s degree or country equivalent in Engineering, Science, related scientific discipline, or equivalent. Higher degree will be an advantage.
**Key Attributes (experience, skills and technical knowledge)**:
- Minimum 3 years medical device experience; or equivalent combination of education and experience.
- Language Skills: Ability to read, analyze and interpret common business documents. Ability to respond to inquiries or complaints from customers, suppliers, and business partners. Ability to write well. Ability to effectively present information to management.
- Organized, detail-oriented, and able to multi-task and prioritize responsibilities.
- Experience in engineering and manufacturing environments preferred.
- Methodical, neat and clean work habits.
- Strong attention to details.
