Thermo Fisher Scientific is looking for a Sr. Quality Engineer to establish and maintain robust Quality Systems aligned with various regulatory standards, ensuring compliance, driving continuous improvement, and supporting new product introduction.
Requirements
- 3–5 years of Quality Assurance experience in a regulated manufacturing or ISO-qualified environment, complying to 21 CFR 820, 21 CFR 803, ISO 13485, ISO 9001, and IVDR.
- Lead Auditor certification from an accredited agency.
- Advanced proficiency with Excel.
- Strong analytical and critical thinking skills.
- Ability to advise the business while interpreting and applying regulations.
- Clear written and verbal communication skills with the ability to collaborate across functions.
- Strong time management and prioritization abilities.
Responsibilities
- Establish and maintain robust Quality Systems aligned with ISO 13485, ISO 9001, FDA 21 CFR Part 820, USDA, IVDD, and IVDR requirements.
- Collaborate across departments to resolve issues from customer feedback or deviations by leading investigations, root cause analysis, and corrective actions, ensuring accurate documentation and closure.
- Conduct management reviews, internal audits, quality assessments, and change processes; approve procedures and address deviations.
- Review and support validation plans and records to confirm requirements are met and documentation is accurately archived.
- Support NPI projects, ensuring design control requirements are implemented successfully.
- Lead projects and meetings on product issues such as the Material Review Board and Change Control Board, while driving continuous process improvements.
- Assess facilities, personnel, and documentation to confirm compliance and quality.
Other
- Standard (Mon-Fri) work schedule.
- Office environment with some degree of PPE required.
- Proven success leading product launches and compliance projects in a matrixed environment.
- Proactive, self-motivated, and able to deliver results on time.
- Outstanding attention to detail with a commitment to accuracy.
