Senior Quality Engineer

Diasorin•Austin, TX

43d

About The Position

The Sr QA Engineer will be responsible for tasks related to on-going quality programs; quality System development and implementation, validations and process development, design change, corrective and preventive action, change control, and quality audits to ensure that assigned Diasorin products meet established specifications, design criteria and control, quality and regulatory standards and customer requirements. The Senior Quality Engineer will trend quality data, evaluate risk and lead projects supporting continuous improvement. The Senior Quality Assurance Engineer is a leader and a mentor.

Requirements

Bachelor's degree required with a life science or engineering discipline preference
7+ Years Progressively responsible Quality Engineering or Quality Assurance experience in the medical device, IVD, pharmaceutical, or other regulated manufacturing industry.
Proven ability to independently lead complex quality initiatives, including manufacturing transfers, validation programs, quality system improvements, and issue resolution.
Strong knowledge of FDA 21 CFR 820, ISO 13485, IVDR, and ISO 14971
Expertise in validation, risk management, CAPA, supplier quality
Leadership & mentoring skills
Root cause analysis & problem-solving
Excellent technical writing and communication

Nice To Haves

ASQ certifications (CQE, CQA) preferred

Responsibilities

Lead Quality Engineering activities supporting IVD product manufacturing and associated processes.
Provide Quality Assurance oversight for manufacturing transfers and replication of operations from contract manufacturers to internal production facilities, including risk management, validation, change control, and compliance activities.
Review, approve, and provide guidance on validation and qualification activities (IQ, OQ, PQ, process, equipment, software, and MES validation).
Lead and support investigations involving nonconformances, deviations, CAPAs, and supplier quality issues, ensuring effective root cause analysis and corrective actions.
Review and approve design and manufacturing process changes using risk-based decision making.
Provide quality oversight for risk management, design controls, process validation, and manufacturing controls, including PFMEAs and validation master plans.
Support internal audits, supplier audits, regulatory inspections, and continuous improvement initiatives.
Analyze, trend, and present quality metrics and performance data to support quality and business objectives.
Collaborate with cross-functional teams to ensure product quality, regulatory compliance, and operational excellence.