Provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
Key Responsibilities :
Provide medical / clinical guidance and final direction to complaint staff related to event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure.
May review complaint conclusions / closure statements.
Educate complaint staff to understand the medical aspects of complaint information and associated procedures including health risks.
May provide training to complaint staff on patient anatomy and medical conditions, products and procedures, and internal policies and procedures.
Provide support in complaint data and relevant clinical information for regulatory submissions or regulatory agency requests.
Provide training for other Clinicians Quality Compliance and Quality Specialists.
Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff / customers, as needed to support complaint investigation and drive towards resolution
Support Product Safety to maintain Decision Rationale Matrix to guide complaint staff and provide final direction on reporting decisions
Other incidental duties
Education and Experience :
Bachelor's Degree or Equivalent in in related field , 4-5 years years experience of previous related experience in a Medical Device Industry, Quality System, hospital / clinical environment (i.
e. cardiac care, ICU, OR, or cardiovascular / endovascular interventions) Required
Previous experience working in a large manufacturing company Preferred
Additional Skills :
Strong presentation and public speaking skills
Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System)
Excellent documentation and communication skills and interpersonal relationship skills
Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards
Extensive understanding of International Quality System Regulations
Working knowledge of Medical Device regulations, and other applicable regulatory requirements.
Provides consultancy to quality compliance team
Consult in project setting within specific sections of quality compliance area
Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence / control