Quality Engineer/Controlled Substance Program Lead

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc… allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), As a Quality Engineer III and Controlled Substance Program Lead, you’ll help ensure quality excellence and regulatory compliance to DEA across manufacturing operations. You’ll help ensure our products meet the highest Quality and regulatory Compliance 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 and DEA compliance.

The role is responsible for overseeing the Controlled Substance Program to ensure compliance with applicable regulatory requirements and internal quality standards. In addition, the position collaborates cross-functionally with multiple teams to investigate and resolve quality issues, conduct risk assessments, manage CAPA activities, support internal and external audits, and drive continuous quality improvement initiatives. The role requires strong analytical, problem-solving, and communication skills to effectively interface with internal stakeholders, customers, and regulatory agencies while helping establish, maintain, and enhance quality systems and compliance practices.

• Advanced degree with 3+ years of experience in Quality Assurance within a regulated industry OR

• Bachelor’s degree with 5+ years of experience in Quality Assurance within a regulated industry (pharmaceutical, medical device, biotech, or related field)
• Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field

Preferred Certifications

• ASQ Certifications such as: Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)

Technical & Regulatory Expertise

Strong knowledge of:

• cGMP requirements
• ISO 13485 / ISO 9001 standards
• DEA regulations
• FDA, EMA, and other applicable regulatory requirements

Experience with quality systems and processes including:

• CAPA and deviation management
• Change control
• Risk management and FMEA
• Document control
• Internal and external auditing
• Validation and qualification protocols

Skills & Competencies

• Advanced problem-solving and root cause analysis skills
• Strong project management capabilities
• Excellent verbal and written communication skills
• Proficiency with quality management systems/software and Microsoft Office
• Knowledge of statistical analysis and quality tools
• Ability to work independently and collaboratively in cross-functional environments
• Strong attention to detail while maintaining a strategic, big-picture perspective
• Excellent interpersonal and stakeholder management skills

Additional Requirements

• Ability to travel up to 25% as needed
• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

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.