Quality Engineer III Quality Complaint Management

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 Engineer III - Quality Complaint Management, you will oversee the customer complaint quality management system, ensuring compliance with applicable regulations (FDA, cGMP, ISO, etc.). You will own the complaint system procedures while providing guidance to complaint investigators to ensure timely and compliant resolution. In this role, you will monitor complaint trends, assess system effectiveness, and drive quality system enhancements. You will collaborate cross-functionally to resolve quality issues through robust complaint investigations, conduct risk assessments, and manage customer communications. This position requires strong analytical, problem-solving, and communication skills to effectively partner with internal stakeholders and external customers, auditing bodies, and regulatory agencies. You will help maintain robust quality standards while fostering a culture of compliance and continuous improvement.

REQUIREMENTS

• Bachelor's Degree required plus 3-5 years of experience in quality assurance in regulated industry (pharmaceutical, medical device, or biotech)

Preferred Fields of Study:

Engineering, Life Sciences, Chemistry or related technical field

• ASQ certifications (CQE, CQA) desired
• Strong knowledge of c

GMP, ISO

13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)

• Experience with customer complaint handling systems and processes
• Demonstrated expertise in root cause analysis and problem-solving methodologies
• Strong project management and organizational skills
• Excellent written and verbal communication skills
• Proficiency with Quality Management Systems (QMS) and Microsoft Office tools
• Working knowledge of statistical analysis and quality tools
• Ability to work independently and collaboratively in a cross-functional environment
• Strong attention to detail with the ability to maintain a systems-level perspective
• Effective interpersonal skills to influence and collaborate across teams
• Ability to travel up to 10%
• Additional language skills are a plus Compensation and Benefits The salary range estimated for this position based in Minnesota is $75,800.

00-$113,675.00. 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 Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.