Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, 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, you'll help ensure quality excellence and regulatory compliance across manufacturing operations. You'll 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.
You'll work with multiple teams to resolve quality issues, conduct validation and equipment-based 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. You'll help establish and maintain quality standards while supporting a culture of continuous improvement and compliance.
REQUIREMENTS:
Advanced Degree plus 3 years of experience, or Bachelor's 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:
Quality oversight of Calibrations and Metrology
SAP knowledge a plus
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
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
Must be legally authorized to work in the United States now and in the future, without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: 10286239
- Position Id: 2faec9ff56019e1014bcd53a806befe3
- Posted 30+ days ago
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