Quality Engineer III – Quality Complaint Management

Thermo Fisher Scientific • Maplewood, MN

2d • 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. 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)
• Strong knowledge of cGMP, 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%

Nice To Haves

• Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field
• ASQ certifications (CQE, CQA) desired
• Additional language skills are a plus

Responsibilities

• oversee the customer complaint quality management system
• ensuring compliance with applicable regulations (FDA, cGMP, ISO, etc.)
• own the complaint system procedures
• providing guidance to complaint investigators to ensure timely and compliant resolution
• monitor complaint trends
• assess system effectiveness
• drive quality system enhancements
• collaborate cross-functionally to resolve quality issues through robust complaint investigations
• conduct risk assessments
• manage customer communications
• maintain robust quality standards
• foster a culture of compliance and continuous improvement

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees