QA Engineer III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Laboratory Setting Office Warehouse

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 youll help ensure quality excellence and regulatory compliance across manufacturing operations. Youll help ensure our products meet the highest standards while supporting our mission to enable customers to make the world healthier cleaner and safer. This role combines technical expertise with quality oversight to maintain robust quality management systems lead investigations drive continuous improvement and ensure GMP/ISO compliance.

Youll work with multiple teams to resolve quality issues conduct risk assessments manage CAPAs support audits and implement quality initiatives. The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators. Youll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance.

REQUIREMENTS:
Advanced Degree plus 3 years of experience or Bachelors Degree plus 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.)
Expertise in quality systems including:
CAPA and deviation management
Change control
Risk management and FMEA
Document control
Internal/external auditing
Advanced problem-solving and root cause analysis skills
Excellent project management abilities
Strong verbal and written communication skills
Proficiency with quality management software and MS Office
Experience with validation and qualification protocols
Knowledge of statistical analysis and quality tools
Ability to work both independently and collaboratively
Strong attention to detail while maintaining broad perspective
Excellent interpersonal skills for cross-functional collaboration
May require up to 25% travel
Additional language skills may be beneficial