About the role
AI summarisedAs a Quality Engineer III, you will ensure quality excellence and regulatory compliance across manufacturing operations at Thermo Fisher Scientific. This role combines technical expertise with quality oversight to maintain robust Quality Management Systems, lead investigations, drive continuous improvement, and ensure compliance with GMP/ISO standards while supporting the company's mission.
Life SciencesOnsite
Key Responsibilities
- Ensure quality excellence and regulatory compliance across manufacturing operations.
- Maintain robust Quality Management Systems (QMS) through quality oversight.
- Lead investigations into quality issues and drive continuous improvement initiatives.
- Manage Corrective and Preventive Actions (CAPAs) and deviation management processes.
- Conduct risk assessments, including Failure Mode and Effects Analysis (FMEA).
- Support internal and external audits to maintain compliance.
- Implement quality initiatives and help establish/maintain quality standards.
- Interface effectively with internal teams, external customers, and regulators regarding quality matters.
Requirements
- Bachelor's Degree plus 5 years of quality assurance experience in a regulated industry (pharmaceutical, medical device, or biotech).
- Advanced Degree plus 3 years of quality assurance experience in a regulated industry (pharmaceutical, medical device, or biotech).
- Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA).
- Expertise in quality systems including CAPA management, deviation control, and change control.
- Advanced problem-solving and root cause analysis skills.
- Proficiency in quality management software and MS Office.
- Strong verbal and written communication skills.
- Ability to work both independently and collaboratively.