Quality Manager

ThermoFisher Scientific; Bothell (WA); Presencial; USD 105.000 - 145.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Total Rewards package

Medical & dental plans

Vision plan

Paid time off & holidays

Parental leave

Descripción de la vacante

Thermo Fisher Scientific seeks a Quality Manager to lead quality initiatives across our global operations, ensuring compliance with ISO and FDA standards. You will guide continuous improvement, mentor teams, and collaborate with cross-functional partners to protect patient safety and deliver high-quality products and services.

The role emphasizes leadership, regulatory expertise, and the ability to implement robust quality systems, with a focus on Lean/Six Sigma methodologies and a culture of

Formación

• Advanced degree with 6+ years in pharma/med device quality
• Bachelor's degree with 8+ years in quality in regulated industry
• Lead Auditor ISO 9001 preferred
• 3–5 years of leadership/management experience
• Comprehensive knowledge of ISO 9001, ISO 13485, FDA QSR/cGMP
• CAPA, risk analysis, FMEA, root cause analysis
• Experience leading audits and regulatory inspections
• Mentor quality teams and implement quality systems
• Cross-functional collaboration and stakeholder management
• Analytical and problem-solving capabilities
• Clear written and verbal communication
• TrackWise and Document Control Systems
• Lean, Six Sigma experience

Responsabilidades

• Guide quality initiatives and continuous improvement
• Ensure adherence to regulatory requirements
• Maintain a culture of compliance and operational excellence
• Collaborate across functions to drive quality outcomes
• Support protecting patient safety and enabling research

Conocimientos

Quality management

Regulatory knowledge

CAPA

Risk analysis

FMEA

Root cause analysis

Audits

Leadership

Cross-functional collaboration

Project management

Communication

Educación

Advanced degree (any field)

Bachelor's degree in related field

Herramientas

TrackWise

Document Control Systems

Descripción del empleo

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

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.