- Analyze complex event interpretation, event investigation, proper coding, required regulatory reporting, and complaint closure. May review complaint conclusions/closure statements and/or customer letters.
- 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.
- Analyze complex clinical evaluation reports (CER) regulatory submissions, regulatory agency requests, and/or management report including ad hoc report.
- Provide clinical input to Product Risk Assessments (PRA).
- Provide training to complaint staff on products and procedures and internal policies and procedures..
- Support Product Safety to maintain Decision Rationale Matrix (DRM) and utilize DRM for reportability.
- Provide knowledge transfer and product training for team members.
- Other incidental duties: Maintain relevant education/training.
- Excellent facilitation, presentation, and public speaking skills.
- Excellent documentation and communication skills and interpersonal relationship skills. including relationship management skills with ability to drive achievement of objectives.
- Proven expertise in Microsoft Office Suite including Word, PowerPoint, Access, and Excel.
- Proven successful project management skills.
- Full knowledge and understanding of Edwards policies, procedures and guidelines.
- Knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR EU MDR and other applicable regulatory requirements.
- Strict attention to detail.
- Ability to interact professionally with all organizational levels.
- Ability to manage competing priorities in a fast paced environment.
- Ability to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations.
- 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.
- Bachelor's Degree or Equivalent in related field
- Experience in the Medical Device Industry, Quality System, and/or hospital/clinical environment (e.g., cardiac care, ICU, OR, or cardiovascular/endovascular interventions) Required
- Previous experience working in a large manufacturing company Preferred
- 5-7 years of experience required
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Senior Product Quality Clinician - Irvine, United States - TalentBurst, Inc.
Description
Title: Senior Product Quality ClinicianLocation: Irvine, CA 94203
Duration: 12 months (possibility of becoming an FTE based on performance).
Shift: 8AM to 5PM PST (with some flexibility depending on the situation).
100% REMOTE
Summary:
The main function of a Product Quality Clinician is to provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.
Key Responsibilities:
Skills:
Education and Experience:
#TB_HC
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