Quality Assurance Compliance Specialist
Position Scope: Full-Time
XACT Robotics is a rapidly growing medical robotics startup company. Our technology is designed to be compatible with a broad range of imaging modalities, capable of delivering various instruments to a desired target for a wide range of clinical applications and indications.
Working at XACT Robotics allows you to exercise your creativity. We encourage our employees to develop themselves, grow their careers and execute meaningful technologies that make an impact on the lives of patients.
If you have passion, drive, and a winning spirit, don`t miss this opportunity.
- Responsible for the development, ongoing improvement, implementation and management of quality management procedures to ensure that products meet required specifications for quality, function, and reliability.
- Design and implement in collaboration with team leaders training programs to build the capabilities of the team members and verify effectiveness and compatibility with required quality standards. Approve training forms.
- Responsible for document and records control compliance.
- Utilize knowledge and experience to consistently refine QA processes to increase efficiency and decrease errors.
- Manage and maintain customer complaints compliance including complaint handling, classification, documentation, investigation, customer communications and initiating the applicable corrective and preventive actions
- Work with the support team and create the monthly update reports for the technical and commercial teams. Present the monthly complaint status in complaint meetings.
- Review and approve customer responses and ensure proper customer communications in regards to complaints and open investigations.
- Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances and trends in the company QMS.
- Facilitate product and process Corrective and Preventive Action (CAPA) investigations from issue identification through implementation of solution and effectiveness monitoring.
- Project manage all aspects of CAPA activity which includes gaining the commitment of cross functional resources, scheduling CAPA team meetings, and ensuring CAPA deliverables per project timelines.
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available.
Qualifications & Requirements:
- Bachelor’s degree in industrial engineering – advantage.
- At least 3 years of experience in QA roles in the medical device industry or equivalent
- Proven experience in quality management systems process development, working with QMS SW such as Arena, Agile, Dot Compliance – an advantage.
- Management experience – A plus.
- Fantastic organizational skills and attention to detail.
- Excellent communication skills – ability to communicate and present ideas clearly and concisely.
- Ability to multitask and follow through in a fast paced environment.
- Proficiency in using computer applications.
- Mechanical / technical background – advantage.
- Excellent level of written English comprehension.