Associate Quality Engineer
diasorinsp•Austin, TX
About The Position
The Associate Quality Engineer supports the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements and internal quality standards for further manufacture, Research Use Only (RUO) and in vitro diagnostic (IVD) products. This role assists with quality system processes including nonconformance management, CAPA, risk management, and production quality oversight.
Requirements
- Bachelor's Degree and/or equivalent experience in a Life Sciences discipline (Biochemistry, Chemistry, Microbiology, etc.) or Engineering discipline (Mechanical, Electrical or Industrial Engineering).
- 1+ Years related experience in IVD, medical, pharmaceutical, or other related industry.
- Proven experience in Process, Product, and/or Method Validation is required.
- Foundational understanding of quality principles and regulated environments
- Strong organizational and documentation skills
- High attention to detail and accuracy
- Analytical mindset with willingness to learn root cause methodologies
- Effective written and verbal communication skills
- Ability to work collaboratively in cross-functional teams
- Proficient in Microsoft Office and data entry systems
Nice To Haves
- ASQ Certified Quality Engineer preferred.
Responsibilities
- Support documentation updates and quality records maintenance
- Assist with change control, deviations, and nonconformance processing
- Support equipment qualification and validation activities under supervision
- Participate in data collection, trending, and metric reporting
- Assist with internal audit preparation activities
- Support complaint investigations and basic CAPA activities as assigned
- Learn regulatory requirements applicable to IVD product
- Provide general quality support to manufacturing and engineering teams
- Support and participate in other QA related activities as required
- Other duties as assigned
Benefits
- competitive rewards package
- comprehensive plan of health benefits
- retirement and financial wellbeing
- time off programs
- wellbeing support and perks
- annual incentive program
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
