Quality Engineer II

Location: Austin, Texas, United States of America

Category: Quality & Regulatory

Employment Type: Full time

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.), Warehouse

Job Description

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.

Location/Division-Specific Information:

Austin, TX. Relocation assistance is NOT provided. 

*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 screen.

Discover Impactful Work:

Join Thermo Fisher Scientific's Quality Assurance team and contribute to our mission to make the world healthier, cleaner and safer. As a Quality Engineer II, you will ensure compliance with quality standards and regulatory requirements across our manufacturing operations. You'll collaborate with cross-functional teams to drive continuous improvement initiatives, lead investigations, and implement corrective actions to maintain our high standards of product quality. This role offers exposure to innovative technologies and the opportunity to directly impact patient care through quality oversight of critical products.

A Day in the Life:

• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Provide Quality Assurance oversight throughout the life cycle of projects to ensure alignment to procedures as required by QMS
• Perform quality review and approval of procedures, reports, training documents and forms as designated by supervision
• Collaborate with product development and sustaining teams including manufacturing to implement robust quality control, improve processes and make recommendations for better practices where applicable
• Perform analysis of the external and internal product quality data
• 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
• Review validation plans and completed validations to ensure quality and product requirements are met, archive records
• Participate in risk assessment process (FMEA)
• Prepare clearly written business communications, including audit reports, gap assessments, meeting minutes, customer letters
• Participate in internal audits, third-party audits, external customers, and agency inspections
• Find opportunities for continuous improvement of the Quality System and drive implementation
• Perform other quality systems duties and projects as assigned

Keys to Success:

Education and Experience

• Advanced Degree with no prior experience, or Bachelor's Degree plus 2 years of quality assurance experience in GMP/ISO regulated environments, preferably in medical devices, pharmaceuticals or biotechnology
• Preferred Fields of Study: Life Sciences, Engineering, Chemistry or related scientific/technical field
• ISO 13485/FDA Lead Auditor certification beneficial
• ASQ certification (CQE, CQA) advantageous
• Strong knowledge of quality systems, cGMP regulations, and standards including ISO 13485, 21 CFR Part 820
• Expertise in quality tools and methodologies including risk management, root cause analysis, CAPA, and change control
• Demonstrated experience leading investigations, analyzing quality data, and implementing effective corrective actions
• Excellent documentation and technical writing skills for developing SOPs, protocols and reports
• Strong computer skills (Office, Project, Teams, Visio, Word, Excel) and experience in E1, SAP, Agile, TrackWise, and Power BI. Advanced computer skills preferred, including a high level of proficiency in Excel
• Dedicated, demonstrated ownership and responsibility
• Experience conducting internal audits and supporting external regulatory inspections
• Demonstrated ability to build consensus and collaborate across functions
• Strong verbal and written communication skills
• Ability to work independently while contributing effectively in team environments
• Strong attention to detail with analytical and problem-solving capabilities
• Experience with statistical analysis tools and quality metrics reporting
• Project management skills and ability to prioritize effectively
• Ability to work in clean room environments when required

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!