Quality Specialist III

at  Thermo Fisher Scientific

EDUCATION

Bachelor’s Degree required

EXPERIENCE

5+ years of quality management system experience.
Ability to understand various Quality management system processes including ISO 13485 and CFR820.
Excellent communication and mentor/guiding skills.

PREFERRED EXPERIENCE

• Strong shown understanding of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
• Understanding of various manufacturing processes and quality processes.
• Excellent written and interpersonal skills.
• Ability to work well with/lead all levels of the organization.
• Develop and implement procedures.
• Ability to perform investigative processes as well as critical thinking and problem solving.
• Knowledge of statistical based computer programs such as Excel and/or Minitab, as well as Microsoft Office.
• Strong Root Cause/Problem Solving skills

KNOWLEDGE, SKILLS, ABILITIES

• Detail Oriented
• Knowledge of Project Management Tools – Schedule Planning (Gantt charts / 4-blockers) and Task Tracking (Meeting Minutes, Action Items & Reminder Notifications)
• Positive demeanor and shown social skills
• Ability to prioritize and run multiple projects simultaneously
• Ability to influence without authority
• Ability to develop high levels of credibility and forge validated and positive professional relationships with subordinates, peers and upper management
• Proficient in Microsoft Office Applications
• Ability to travel (<10%)
  Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one distributed team of 140,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, address sophisticated scientific challenges, drive technological innovation and support patients in need.
  Apply today! http://jobs.thermofisher.com

• Site Steward for Trackwise
• Trackwise records management and associated results.
• Collect, analyze and present site critical metric data via appropriate channels (e.g. CAPA Review Board, Management Review, Tier Cascade)
• Track and trend process and product performance data to drive process and program performance.
• Review, edit and approve existing procedures.
• Build new SOPs as appropriate to close QMS gaps and drive continuous improvement.
• CAPA timeline management.
• CAPA Improvement
• Investigate and perform RCA (root cause analysis) activities; cascade knowledge and work with functional department owners/leads.
• Interact/lead deviation management activities as a cross-functional team.