Description
Quality Specialist
Organization Description:
We simplify healthcare by focusing on the people in the care cycle - patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Client delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home. Some product highlights: 256-slice Brilliance iCT scanner, integrated cath lab, Avalon FM 20 & FM 30 fetal monitors, Ambient Experience MR and CT systems, and Client's Lifeline's personal emergency alert service. Our department provides quality and regulatory function for the Emergency Care Solutions business within Therapeutic Care.
Responsibilities:
- Assist with complaint investigations in accordance with internal and external (FDA, Canadian and European) regulatory requirements.
- Coordinate complaint investigation communication and general information gathering.
- Investigates customer complaints related to product quality and patient safety
- Identify potential safety problems.
- Support the investigation of complex clinical and technical issues.
- Utilizing product knowledge, verify a reported problem and if necessary get the appropriate product specialist or Engineer involved to verify the problem and document root cause.
Profile:
- Requires strong written, oral and interpersonal skills.
- Plans, organizes, and prioritizes own work routine to meet established schedule and support the activities of Q&R.
- Proficient computer skills in Microsoft Office applications
- Experience investigating device malfunctions or customer problems is preferred
- Strong analytical and problem solving skills.
- Previous experience in a medical device company preferred
- Previous experience with FDA medical device regulations, safety standards and regulatory compliance guidelines preferred.
- Complaint handling experience preferred
- College degree preferred, but not required