Quality Engineer III – Quality Complaint Management

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds 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:
Bachelors 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 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%

Additional language skills are a plus

Compensation and Benefits

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: Experience:

IC