Quality Systems & Compliance Specialist III

at  Thermo Fisher Scientific

JOB DESCRIPTION

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

EDUCATION

• Bachelor’s Degree is required (Biological sciences, Engineering, or related degree); advanced degree is a plus.
• 10+ years of related experience in the quality systems

EXPERIENCE

• Experience working in regulated environments and knowledge of applicable regulations/standards to GSG business including 21CFR820, 21CFR803, ISO 13485, ISO 9001, IVDR, cGMPs, FDA Guidelines, USP, GxP.
• Has effectively lead compliance projects and cross-functional teams.

KNOWLEDGE, SKILLS, ABILITIES

• Must demonstrate strong critical thinking and analytical skills, and be self-motivated, proactive, and able to complete projects on time.
• Strong verbal and written communication skills and can effectively communicate at multiple levels in the organization.
• Results oriented with track record of developing, motivating, and leading strong/effective teams
• Ability to travel.

• Liaison directly with site Quality Managers in support of the Quality System initiatives including Change Control, Field Corrective Actions (FCA), CAPA, Complaints, Internal/External Audits.
• Lead continuous improvement initiatives to ensure the Quality Management System (QMS) is implemented effectively by trending data and using metrics to analyze performance.
• Collaborate cross-functionally to identify, develop, build, and implement Divisional QMS policies and procedures.
• Manage and deliver on projects to drive continuous quality excellence.
• Participate, advise, and support in FDA inspections, ISO and customer audits, and support external audit response management for LSG.
• Maintain knowledge of regulations and stay abreast of all regulatory changes relevant to industry and organization.
• Act as a SME supporting product/development team members in order to ensure compliance requirements are being met during the refinement process through release readiness.
• Support a proactive approach toward investigation and resolving potential product compliance issues.
• Other duties as assigned