Quality Specialist

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.
- Philips 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, Philips 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