Senior Quality Engineer

Senior Quality Engineer

• Medical Device

Location: Austin, TX

Why join?

I am working with a leading medical device manufacturer, specialising in innovative healthcare products. This role provides Quality Engineering leadership for new product development and product line support, ensuring compliance with federal, industry, and corporate standards.

Key responsibilities & Requirements

• Lead Quality Engineering for new product development and transfer to manufacturing
• Provide technical leadership resolving quality issues
• Create, review, and approve protocols, process/product validations, and Design History File documents
• Analyze non-conformances and drive corrective/preventive action plans (CAPA)
• Perform internal and supplier quality system audits
• Develop Validation Master Plans and Project Plans
• Partner cross-functionally on design controls, risk management (FMEAs), and design verification/validation
• Investigate and resolve CAPAs and customer complaints
• Bachelor's degree in Engineering or science, or equivalent experience
• 4+ years hands-on experience, ideally in an FDA-regulated industry (pharma, biomedical, medical device)
• Strong grip on cGMP, QSR, and ISO Standards; statistical methods and acceptance sampling
• ASQ, CQE, or CQA certification a plus

Benefits

• Medical, dental, vision
• 401(k)
• Unlimited PTO
• Progression plan

Apply Today: Send your resume to [email protected] or call +1 651 -432-4858