Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

As a Quality Engineer III, you'll ensure quality excellence and regulatory compliance across manufacturing operations, meeting the highest product standards and supporting the 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.

Responsibilities

• 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.
• Serve as a backup for other Quality roles and fulfill other duties as assigned.

Requirements

• 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.
• 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).
• 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.

Skills

• CAPA and deviation management
• Change control
• Risk management and FMEA
• Document control
• Internal/external auditing
• Statistical analysis
• Quality tools
• MS Office

Location

• Austin, TX

Work Type

• Office
• Standard (Mon-Fri)

Experience Level

• 3 years of experience (with Advanced Degree)
• 5 years of experience (with Bachelor's Degree)

Education Level

• Advanced Degree
• Bachelor's Degree
• Engineering
• Life Sciences
• Chemistry
• ASQ certifications (CQE, CQA)
• Lead Auditor certification

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits

About the Company

• Thermo Fisher Scientific is an innovative, forward-thinking organization with outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.