Job Title: QA Manager
Reports To: VP, QA-RA
Position Scope: Full-Time
Position Level: Mid-Level
About XACT Robotics:
XACT Robotics prides itself on finding the best talent, expecting extreme ownership, and maintaining a culture that is unparalleled. A career at XACT Robotics is more than a job, its personal. Employees have passion, drive, and a winning spirit that allows for a fast-paced environment that is effective, empowering and fun.
Quality assurance in medical devices involves a wide range of processes affecting the quality of medical devices and associated products, throughout the entire life cycle of the device, from design and development until after years of the product being used in the market. Quality assurance is supported by a Quality System, which has been established in compliance with relevant standards and regulations. Managing the Quality System in a medical device company, which continuously strives to develop and produce state of the art devices for patients, to better diagnose and treat disease, is more important than ever.
Medical device quality assurance positions involve overseeing all aspects of device quality, producing quality documentation, maintaining, and enhancing the quality management systems, carrying out product quality reviews and performing audits to ensure that all devices comply with regulatory requirements.
- Responsible for developing and implementing the annual quality objectives.
- Directs the daily activities of the Quality Assurance staff.
- Responsible for quality assurance (QA) & quality control (QC) activities in Production and Operations. These activities include monitoring actual defined processes as well as addressing nonconformance and other deviations.
- Responsible for supplier quality including Full Turnkey suppliers, contract manufacturers and other service providers. Perform audits at suppliers and work with them on enhancing the quality of items / services provided to XACT Robotics.
- Designs the measurement techniques, audits and data reports which evaluate the attainment of the quality objectives and the efficiency of the quality system.
- Take a major role in facilitating design changes as well as ensuring that changes are adequately verified / validated and documented.
- The Quality Manager has significant contribution to processes of regulatory accreditation including preparing for audits / inspections, maintaining a constant state of audit-ready, compliance with standards, and promoting a culture of safety.
- QA in the production line
- Facilitates CAPA and other committee meetings where Quality Data is periodically reviewed striving to continuous improvement.
- Participate in Risk Management / Risk Analysis activities ensuring that relevant risks and hazards are identified and that adequate mitigations are considered and defined. Use risk-based approach to enable proportional response.
- Use information collected through post-marketing surveillance activities to initiate improvement projects.
Qualifications & Requirements:
- Bachelor’s degree required in Engineering or other related life science field; Master’s Degree preferred.
- Minimum of 5 years progressive experience in Medical Device industry dealing with quality management, medical staff, systems improvement, and accreditation standards.
- Capable of leading various assignments including ones characterized with higher level of complexity.
- Can resolve professional challenges independently with minimal guidance from his supervisor. Can efficiently draw meaningful conclusions and implement lessons learned.
- Minimum of 3 years management experience Can coach and mentor other employees.
- Relevant experience to lead the QA management systems. Both planning and implementation (from a project management perspective).
- Minimum 5 years’ experience and having a deep knowledge of QA processes in the production line.