Quality Manager

Thermo Fisher Scientific•Bothell, WA
•$105,000 - $145,000•Onsite

About The Position

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. As a Quality Manager at Thermo Fisher Scientific, you will contribute to excellence across our quality management systems while enabling our mission to make the world healthier, cleaner and safer. You will guide quality initiatives, support continuous improvement, and cultivate a culture of compliance and operational excellence. Working collaboratively across functions, you will ensure adherence to regulatory requirements while maintaining the highest quality standards for our products and services. This role offers the opportunity to make a meaningful impact by protecting patient safety, supporting innovative research, and enabling critical scientific discoveries.

Requirements

  • Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in quality experience in pharmaceutical, medical device or regulated industry
  • Preferred Fields of Study: Chemistry, Biology, Engineering, Pharmacy, or related scientific/technical field
  • 3-5 years of leadership/management experience
  • Comprehensive knowledge of quality management systems and regulations (ISO 9001, ISO 13485, FDA QSR/cGMP)
  • Strong understanding of quality tools and methodologies (CAPA, risk analysis, FMEA, root cause analysis)
  • Demonstrated ability to develop and mentor quality teams
  • Successful experience implementing and improving quality systems
  • Skill in cross-functional collaboration and stakeholder management
  • Strong analytical and problem-solving capabilities
  • Clear written and verbal communication skills
  • Proficiency with quality management software (TrackWise, Document Control Systems)
  • Experience with continuous improvement methodologies (Lean, Six Sigma)
  • Ability to promote quality culture across all levels
  • Focus on customer needs

Nice To Haves

  • Lead Auditor certification in ISO 9001 preferred
  • Project management experience preferred

Responsibilities

  • Guide quality initiatives
  • Support continuous improvement
  • Cultivate a culture of compliance and operational excellence
  • Ensure adherence to regulatory requirements
  • Maintain the highest quality standards for our products and services
  • Develop and mentor quality teams
  • Implement and improve quality systems
  • Collaborate cross-functionally and manage stakeholders
  • Promote quality culture across all levels
  • Manage customer/supplier relationships
  • Lead internal/external audits and regulatory inspections

Benefits

  • Choice of national medical and dental plans
  • National vision plan
  • Health incentive programs
  • Employee assistance and family support programs
  • Commuter benefits
  • Tuition reimbursement
  • At least 120 hours paid time off (PTO)
  • 10 paid holidays annually
  • Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave)
  • Accident and life insurance
  • Short- and long-term disability
  • Competitive 401(k) U.S. retirement savings plan
  • Employees’ Stock Purchase Plan (ESPP)
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