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Quality Assurance Specialist

3 months ago

Garden Grove, United States Hycor Biomedical, LLC Full time

**THE ESSENTIAL FUNCTIONS OF THIS POSITION ARE AS FOLLOWS**:

- ** Oversee the CAPA system, ensuring timely identification, investigation, and resolution of quality issues.**:

- ** Lead root cause analysis and implement effective corrective and preventive actions.**:

- ** Monitor CAPA effectiveness and maintain detailed records of all activities.**:

- ** Track and manage nonconformance reports, ensuring proper documentation and resolution.**:

- ** Collaborate with relevant departments to investigate nonconformances and implement corrective actions.**:

- ** Analyze trends in nonconformance data to identify areas for improvement.**:

- ** Monitor and handle deviations from standard procedures, ensuring proper documentation and corrective actions.**:

- ** Conduct thorough investigations to determine root causes and prevent recurrence.**:

- ** Conduct risk assessments for processes, products, and systems to identify potential hazards and implement risk mitigation strategies.**:

- ** Maintain risk management files and ensure compliance with regulatory requirements.**:

- ** Collaborate with cross-functional teams to integrate risk management into the quality management system.**:

- ** Participate in quality improvement projects and initiatives to enhance the effectiveness of the quality management system.**:

- ** Provide training and guidance to staff on CAPA, nonconformance, deviation, and risk management processes.**:

- ** Generate, maintain and report to management on the status of Quality Improvement Plans.**:

- ** Solve a wide range of issues that impact multiple functions, following QSR regulations and international standards.**:

- ** Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.**:

- ** Collaborate with Management to establish and meet targets and timelines.**:

- ** Collaborate with resources to identify, design, and implement process and system improvements.**:

- ** Maintain sound knowledge of QSR, IVDR, ISO 13485, 14971 standards.**:

- ** Interpret and relate Quality standards for implementation and review.**:

- ** Support FDA and other regulatory body inspections.**:

- ** Demonstrate flexibility in problem solving, providing direction and work hours to meet business objectives**

**Education**:
**Bachelor degree in life science or physical science.**

**Licenses/Certifications**:
**None.**

**Skills/Abilities**:
**Thorough understanding of present day quality systems for biomedical and pharmaceutical manufacturing. Reading, writing, proofreading and verbal communication skills. Ability to interact well with other departments. Detailed understanding of ISO 13485, IVDR, and 21 CFR 820. Ability to handle multiple assignments with efficiency. Detail oriented.**

**Experience**:
**3+ years of experience in a related industry.**

**As a team member of Hycor, you will enjoy**:

- **Comprehensive benefit package, including health, vision, and dental insurance.**:

- **401k**:

- **PTO**:

- **_Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time._