Quality Assurance Specialist

The primary responsibility of this position is to support the R&D, manufacturing, sales, and marketing teams during from design and development through manufacture, distribution, and sales to End of Product Life.

Essential Responsibilities and Accountabilities:

• Develop and maintain quality programs, systems, processes, and procedures to ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and regulations.
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Responsible for driving quality programs, continuous improvement projects, and CAPA investigations and solutions to ensure appropriate measures are implemented to prevent recurrence
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of audits.
• Supports the NCMR programs and ensures appropriate disposition of nonconforming parts
• Supports all departments to ensure a timely root cause identification for process/product deviations
• Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques: experimental design, data analysis, sampling techniques and other traditional QA Engineering activities.
• Review device history records and release of products
• Support new product introductions, qualification of new suppliers, development and approval of new product documentation.
• Develop and maintain documentation in compliance with FDA, ISO, MDR, IVDR requirements
• Implement and perform post-market surveillance
• Other duties as assigned

Qualifications:

• Knowledge of Quality system principles; FDA Quality System Regulation (cGMP); 21CFR820, ISO 13485 Quality system standards for medical device, IS017971 Risk Management Systems is preferred.
• Knowledge of inspection methods and sampling plans for in vitro diagnostic products, statistical analysis, and the application of Six Sigma, Kaizen, and Lean Manufacturing techniques is desired.
• Experience in FDA regulated environment preferred.
• ASQ Certification Preferred.

Skills and Competencies:

• Strong organization and communication skills.
• Excellent team player with strong interpersonal skills.
• Comfortable working in a fast-paced environment while keeping to tight deadlines.
• Proficiency with Microsoft Office Tools.
• Exposure to Statistical software is preferred but not required.

Education/Experience:

• Bachelor’s degree in Science, Engineering, or a related field.
• Experience in the medical device industry or related field is preferred.