The Quality Specialist will support the Genetic Testing Solutions (GTS) Business Unit with an emphasis on Post Market Surveillance in the development and sustainable improvement of products that continuously meet customer expectations. Develop and maintain proactive communication with manufacturing sites regarding meeting quality standards, anticipating future requirements and interpreting customer expectations and regulatory requirements. Responsibility may include liaison with external and cross-functional internal parties on matters relating to quality concerns and driving resolution of issues as agreed upon by the GTS leadership team.

Responsibilities

• Analyze and trend all types of data (CAPA, problem records, complaints, on-market surveillance) to identify deficient areas and initiate quality improvement projects
• Coordination and execution of Global Field Safety Notice/Customer Communications/Recalls including documentation of effectiveness
• Participate in departmental projects and improvement initiatives through the site’s PPI Program and partner with other groups to continuously improve
• Identify, compile and refine metrics for quality and operation reports.
• Participate in and lead internal audits per ISO 13485 and 9001 requirements and ensure site audit readiness

Required Skills

• Proven ability to effectively develop, communicate, and gain support cross functionally and with a wide range of stakeholders.
• Excellent understanding of regulations and standards such as; 21 CFR 820, ISO 13485, ISO 9001, or similar standards/regulations.
• Excellent judgment and creative problem-solving skills, excellent interpersonal skills, organizational skills, written and oral communication skills
• Strong computer skills (Office, Project, Teams, Visio, Word, Excel)
• Experienced with Quality tools, methodologies, and complaint investigations, including root cause analysis
• Demonstrated skills in project management
• Ability to work independently as an individual contributor
• Energetic, flexible, collaborative and proactive

Required Experience

• Bachelor's Degree is required (Biological sciences or related degree); advanced degree is a plus
• 3-5 years of experience supporting a Quality Management system in a regulated industry (drugs, biologics, medical devices, or related industry)

Travel

International and Domestic – 25 -50 %