Overview
Quality Engineer Jobs in Austin, Texas Metropolitan Area at United Pharma Technologies Inc
Title: Quality Engineer
Company: United Pharma Technologies Inc
Location: Austin, Texas Metropolitan Area
Senior Quality Engineer – Validation & Risk Management
Location: Austin, TX
Qualifications
- Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline
- 5–10 years of Quality Engineering experience in Medical Device, Biomedical, Pharmaceutical, or other FDA-regulated industries
- Strong knowledge of FDA Quality System Regulations (QSR), GMPs, and ISO standards
- Proven experience executing equipment and process validation projects
- Advanced understanding of statistical methods and data analysis tools
- Strong technical writing skills with demonstrated experience authoring validation protocols and reports
- Risk Management experience preferred
- ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certifications preferred
Key Responsibilities – Validation & Quality Engineering
- Lead equipment and process validation activities throughout the product lifecycle
- Develop, execute, review, and approve IQ/OQ/PQ protocols and validation reports
- Support validation efforts related to facility expansions and equipment transfers
- Review and approve equipment, process, and software validation documentation
- Perform test method validations and GR&R studies
- Analyze validation data and provide statistical justification for process acceptance
- Support calibration and preventive maintenance programs in collaboration with Facilities
New Product Development & Technical Transfer
- Provide Quality Engineering support for New Product Development (NPD) and technology transfer projects
- Collaborate with Engineering and Manufacturing teams to support commercial product launches
- Ensure proper implementation of design controls and quality requirements
- Assist in translating design inputs into manufacturing-ready design outputs
- Support Design History File (DHF) documentation activities
