The Quality Specialist will support the Genetic Testing Solutions (GTS) Business Unit in the development and sustainable improvement of products that continuously meet customer expectations. Develop strategies and translate these into realistic projects utilizing QA, R&D and Manufacturing resources. Develop and maintain proactive communication with manufacturing sites regarding meeting quality standards, anticipating future requirements and interpreting customer expectations and regulatory requirements. Participate in developing global quality standards to meet both regional and international requirements alongside Product Development. 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

• Represent GTS Quality in New Product Introductions, Project Action Committees and Change Control Boards focused on products leveraged with defined clinical workflows with an emphasis on instrumentation and software.
• Perform continuous quality control evaluation and trend analysis on product quality issues and direct/initiate corrective actions with other departments as required.
• Partner with R&D, Product Management and Site Manufacturing on quality investigations. Drive/Participate in GTS Quality Tiger Teams.
• May conduct internal and external audits ensuring compliance applicable international and national standards, regulations, and guidelines.

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
• Ability to work independently as an individual contributor
• Demonstrated skills in project management
• 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 developing, implementing, or maintaining a Quality Management Systems in a regulated industry (drugs, biologics, medical devices, or related industry)

Travel

International and Domestic – 25 -50 %