Sr. Product Quality Clinician

Sr Specialist, Product Quality Clinician

Location: Irvine, CA (100% Remote)

Remote position but candidates will need to work PST hours

Duration: 6+ months contract with high possibilities of extension/conversion

Job Description:

The main function of a prod quality clinician is to provide clinical expert knowledge and clinical guidance to Quality Specialists to understand the nature of complaints and possible health risks.

Education and Experience:

• Registered Nurse or Licensed Vocational Nurse (highly preferred)
• Bachelor's Degree or Equivalent in a 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 is preferred.
• 5-7 years of experience required

Skills:

• Excellent facilitation, presentation, and public speaking skills
• Excellent documentation and communication skills and interpersonal relationship skills including relationship management skills with the ability to drive the 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 the client's 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 the environment and prevention of pollution under their span of influence/control

Key Responsibilities:

• 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 the 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

Why TalentBurst?

At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.