Quality Manager

Regulatory Jobs; Bothell (WA); On-site; USD 105,000 - 145,000; Full time

Benefits offered by this job

Medical plans

Dental plan

Vision plan

PTO 120 hours

Holidays

Parental leave

401(k) plan

ESPP

Job summary

Thermo Fisher Scientific seeks a Quality Manager to drive quality initiatives and maintain compliance across our quality systems. You will guide continuous improvement, mentor teams, and support regulatory inspections while protecting patient safety and enabling scientific innovation.

Collaborating across functions, you will ensure adherence to ISO and FDA requirements, promote a culture of quality, and lead efforts to optimize quality tools and processes.

Qualifications

• Advanced degree with substantial quality experience.
• Experience in pharmaceutical, medical device, or regulated industry.
• Lead auditor certification in ISO 9001 preferred.
• Strong regulatory knowledge (ISO 9001/13485, FDA QSR/cGMP).
• Experience leading audits and regulatory inspections.
• Mentor and develop quality teams.

Responsibilities

• Lead quality initiatives and continuous improvement across functions.
• Ensure compliance with regulatory requirements and quality standards.
• Guide teams in CAPA, risk analysis, and root cause analysis.
• Collaborate to maintain high product and service quality.

Skills

Quality management

Regulatory compliance

Auditing

Leadership

Cross-functional leadership

Problem solving

Data analysis

Project management

Communication skills

Lean Six Sigma

Education

Advanced degree

Bachelor's degree

Tools

TrackWise

Document control systems

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

DESCRIPTION: 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
• Lead Auditor certification in ISO 9001 preferred
• 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)
• Experience leading internal/external audits and regulatory inspections
• 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 and ability to manage customer/supplier relationships
• Project management experience preferred

Compensation and Benefits

The salary range estimated for this position based in Washington is $105,000.00–$145,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and 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, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards