Job ScopeThe 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.
Duties and 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.
Education, Experience and Qualifications- Bachelor's degree required with a life science or engineering discipline preference Required
- 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. Required
- ASQ certifications (CQE, CQA) preferred
Training and Skills- 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
Travel- 10% Travel may be required
What we offerReceive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.
Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.
