Quality Compliance Specialist
Roth Staffing Companies

Job Info

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Our client who is a medical technology company is currently seeking a remote Quality Compliance Specialist.

Location: Irvine, CA 92614

Pay Rate: $43.00-$47.24/hour

REMOTE

Duration: 9 month Contract

Job Summary:

The primary responsibility of the Quality Compliance Specialist is to assess provided complaint information, evaluate each event to determine if it qualifies as a complaint, and escalate as necessary. This role involves managing customer relationships throughout the complaint investigation and resolution process, collaborating with various departments for investigation support, and leading projects to enhance processes. Additionally, the specialist is responsible for preparing and submitting Medical Device Reporting (MDR) reports to regulatory agencies, summarizing findings, and facilitating communication with relevant stakeholders to address complaint issues.

Key Responsibilities:

• Manage customer relationships and expectations during complaint investigation and resolution.
• Collaborate with Product Safety, Engineering, and other departments for complaint investigations.
• Identify problems and lead projects to improve processes, procedures, and practices.
• Evaluate complaints for Medical Device Reporting (MDR) and prepare submissions to regulatory agencies.
• Summarize investigation findings and formulate conclusions.
• Prepare and submit final customer correspondence.
• Assist in planning agendas and running meetings to discuss complaint issues with affected functions.

Additional Skills:

• Experience in medical device, healthcare, or related environments.
• Proficiency in MS Office Suite and general office machinery operation.
• Strong written and verbal communication skills.
• Excellent problem-solving, critical thinking, and investigative abilities.
• Familiarity with Edwards policies, procedures, and quality compliance guidelines.
• Knowledge of medical terminology and human anatomy.
• Understanding of Medical Device Reporting regulations and regulatory reporting.
• Familiarity with Good Documentation Practices (GDP) for complaint filing.
• Ability to handle confidential information with discretion.
• Attention to detail and professionalism in all interactions.
• Capacity to manage competing priorities in a fast-paced environment.

Education and Experience:

• Bachelor's Degree or equivalent in a related field.
• 5-7 years of relevant experience required.

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

This job has expired.