Cerus
Quality Assurance Engineer III
Concord, California · Mid
Sponsorship not specified$121k-$148kDetected 14 days ago
AuditingProcess ImprovementMedical DevicesCommunication
About the role
- We understand that our people are essential to our success.
Responsibilities
- Participate in cross-functional teams to support new and sustaining product development, quality improvement, quality plans, risk management, and cost savings projects.
- Perform risk analysis of production, process, and quality data to identify trends and recommend improvements to reduce and control manufacturing process defects and improve quality.
- Perform product release and product quality reviews.
- Maintain quality tracking tools and dashboards (e.g., Smartsheet-based RMA, CAPA, supplier action, and field issue tracking) to improve visibility, accountability, and closure timelines.
- Participate in developing and implementing methods and procedures for inspecting, testing and evaluating raw materials, components and finished products.
- Support risk management review meetings and ensure quality documentation meets risk management
- Create and review regulated documents associated with the design and manufacture of Cerus products such as SOPs, specifications, verification and validation protocols and reports, quality control and reliability plans etc.
- Conduct internal and supplier audits to support Cerus quality management
- Support QA internal and supplier Audits.
- Provide support on CAPA investigations and effectiveness
Requirements
- Bachelor's degree or equivalent in engineering or scientific discipline
- Experience with developing and monitoring Key Process Indicators (KPIs) is desirable.
- ability to adapt to changing.
- Perform other related duties as required.
Skills
- Familiarity with software testing methodologies and defect management.
- Experience creating and executing test cases, including traceability to requirements.
- Quality certification desired (Six Sigma, CQA, CRE).
- Experience with defining and monitoring supplier quality agreements is desirable.
- Ability to work effectively with cross-functional.
- Strong communication skills (encompasses verbal, written, interpersonal, listening).
- Attention to detail and accuracy; very observant to audit.
- Ability to use quality tools such as FMEA/HA, DOE, Six Sigma, SmartSheet, Veeva.
- Flexible; ability to adapt to changing.
- Willing to travel domestically and internationally (approximately 10% as needed).
- Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation
- The base salary range for this position in the selected city is $121,000-$148,000 annually<span style="
Benefits
- EAP, legal and financial services, health club membership discounts, tuition reimbursement
This listing is sourced directly from Cerus's careers page and normalized into a canonical job model.