QMS Compliance Leader

Magenta is a medical device company developing the world’s smallest heart pump, which is meant to provide minimally invasive support to the heart during acute episodes of dysfunction. The Elevate™ System is multidisciplinary, involving mechanical engineering, material science, electrical engineering, software, algorithms, and state-of-the-art catheter fabrication techniques.

We seek the best people to help us advance the Elevate™ System and save more lives.

We are currently looking to hire an experienced QMS Compliance Leader to join our QA group and lead and manage all QMS compliance, monitoring, and analysis activities, such as:

Document Control Management:

• Manage all documentation control processes and serve as the Administrator of “Dot Compliance” (an eQMS implemented in Magenta).
• Maintain critical company documents, such as SOPs, Training Records, Design Files, Validations, Device History Files, and Device Master Records.
• Manage documentation and engineering change control process.
• Maintains current and accurate files for all DHFs and Technical Files.
• Manage training for personnel to ensure effective and compliant execution of document change control.

CAPA Management:

• Leads CAPA activities including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Participate in all aspects of the corrective/preventive action system (CAPA).
• Provide guidance/training to personnel performing CAPA activities.

Training Management:

• Responsible for managing company training program: mapping company training needs, training plan, and employees training files and competencies matrix.
• Preparing QMS training materials, performing QA orientation training for new employees, perform ongoing QA general training.

QMS Monitoring:

• Quality Management Process monitoring and analysis per measurable process indicators.
• Implementation of QMS SW tools: assist with mapping and selection of a QMS management software solution (Define and document requirements, implement the use of a QMS SW tool into the Magenta Quality System and revise procedures accordingly, perform validation of the software tool, and write a report).
• Perform Internal Audits and supplier audits, as required.
• Prepare and lead Management Review activities.

Complaints Management:

• Manage and implement the complaints handling process in the company, from initiation, through investigation and closure.

Qualifications

• B.A. or B.S. degree in a technical discipline, such as Engineering or Science.
• 5+ years of relevant experience in the medical device industry.
• Previous experience with medical device verification/validations, ECOs, medical device statistics
• Working knowledge of medical device international standards.
• Ability to work independently with minimal direction and in a cross-functional team environment.
• Fluent in English with excellent writing skills and practical written and verbal communication skills.
• Excellent computer skills, including a working knowledge of Microsoft Office applications.
• Strong time management abilities to ensure timely task completion.
• Detail-oriented.