Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Location/Division-SpecificInformation:
Austin, TX. Relocation assistance is NOT provided.
*Must be legally authorized to work in the United States withoutsponsorship.
*Must be able to pass a comprehensive background check, which includes a drug screen.
Discover Impactful Work:
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 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.
A Day in the Life:
- Collaborate with interdepartmental contacts to resolve issues arising from customer complaints or deviations by facilitating investigations, root cause analysis, and corrections/corrective actions to ensure accurate documentation and closure
- Perform management review, quality reviews, internal audits, approval of procedures, deviations, and change control.
- Review validation plans and completed validations to ensure quality and product requirements are met, and archive records
- Support NPI projects, ensuring design control requirements are met
- Lead projects and meetings related to product issues, such as the Material Review Board and Change Control Board, and drive continual process improvement.
- Aid in the identification of continuous improvement opportunities and participate in practical process improvement (PPI) initiatives.
- Perform quality assessments of facility, personnel, and documentation areas to ensure quality and compliance.
- Prepare clearly written business communications, including audit reports, gap assessments, meeting minutes, and customer letters
- Participate in internal audits, third-party audits, external customers, and agency inspections
- Foster a quality culture by helping personnel understand the application of policies and controls.
- The role will provide leadership in planning and execution of activities, acting as a resource and mentor to colleagues, but will not include supervisory or performance management duties.
- Serve as a backup for other Quality roles and fulfill other duties as assigned
Keys to Success:
Education and Experience
- 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) and/or Lead Auditor certification from an accredited agency desired
- Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, USDA, EMA, etc.)
- Expertise in quality systems including: CAPA and deviation management. Change control, Risk management and FMEA, Document control and 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 a broad perspective
- Excellent interpersonal skills for cross-functional collaboration
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!
