Quality Engineer/Controlled Substance Program Lead

Thermo Fisher Scientific•Middletown, VA

32d•Onsite

About The Position

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.

Requirements

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)
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
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
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.

Nice To Haves

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)

Responsibilities

Overseeing the Controlled Substance Program to ensure compliance with applicable regulatory requirements and internal quality standards.
Collaborating cross-functionally with multiple teams to investigate and resolve quality issues.
Conducting risk assessments.
Managing CAPA activities.
Supporting internal and external audits.
Driving continuous quality improvement initiatives.
Establishing, maintaining, and enhancing quality systems and compliance practices.