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Job Title: Senior Quality Engineer – Medical Devices / Quality Systems

Location : Pacheco, CA

Pay range : $50 - $53/HR

Duration : 12+ MONTHS

Position Summary

The Senior Quality Engineer will support the integration and remediation of Quality Management Systems (QMS) within a regulated medical device environment. This role will be responsible for supporting QMS certification maintenance, integrating quality systems, and providing Quality oversight for IVDR remediation activities.

The position will provide hands-on Quality leadership to ensure product quality, regulatory compliance, inspection readiness, and continued compliant product supply during business and operational transitions.

The Senior Quality Engineer will work closely with Quality, Regulatory, Manufacturing, Operations, and global leadership teams to identify and escalate quality and compliance issues, drive remediation activities, and support continuous improvement.

The role may also support the technical transfer of manufacturing and testing activities between sites.

Key Responsibilities

• Support the execution of QMS integration, remediation, and implementation plans while ensuring key quality milestones are achieved.
• Provide Quality oversight for IVDR remediation and implementation activities.
• Support site inspection and audit readiness through Gemba walks, compliance assessments, internal audits, and remediation of identified gaps.
• Monitor compliance with product registration files and applicable regulatory requirements.
• Ensure product release activities are performed in accordance with regulatory standards, approved specifications, and applicable registration files.
• Ensure QC testing methods and specifications meet applicable regulatory and cGMP requirements.
• Develop, implement, and maintain appropriate Quality Plans.
• Develop and monitor quality metrics and KPIs to identify opportunities for product and process improvement.
• Collaborate with Quality and Regulatory leadership to support compliance, certification, and regulatory requirements.
• Support external audits and inspections conducted by health authorities, notified bodies, customers, and business partners.
• Ensure QMS controls and quality processes are effectively implemented and maintained within manufacturing and operations.
• Manage and drive timely closure of NCRs, CAPAs, deviations, and other quality records.
• Support root cause investigations and implementation of effective corrective and preventive actions.
• Provide quality data and reporting for management reviews and quality performance monitoring.
• Provide QA oversight of equipment, system, and process validation and qualification activities, including review and approval of validation plans, protocols, and reports.
• Support supplier quality activities, including supplier audits and follow-up actions.
• Provide Quality support to Manufacturing and Operations, ensuring appropriate controls are established to protect product quality and regulatory compliance.
• Review and approve Device History Records (DHRs) and other applicable batch documentation.
• Support product batch disposition, including release or rejection based on established release criteria.
• Identify quality and compliance risks, escalate issues appropriately, and coordinate cross-functional resources to resolve them.
• Support technical transfer of manufacturing processes and testing activities between sites, as required.

Required Qualifications & Experience

• Bachelor's, Master's, or PhD degree in Science, Engineering, or a related technical discipline, or equivalent industry experience.
• Minimum 5 years of experience in a Quality Engineering or Quality Assurance role within a regulated industry.
• Experience working in medical device manufacturing or a similarly regulated manufacturing environment.
• Strong knowledge of Quality Management Systems (QMS) and applicable regulatory standards.
• Working knowledge of ISO standards, GxP/cGMP, and FDA Quality System Regulation (QSR) requirements.
• Experience interfacing with regulatory bodies, notified bodies, customers, or external auditors.
• Experience with CAPA, NCR/nonconformance management, root cause analysis, and quality investigations.
• Experience supporting audits, inspections, and inspection readiness.
• Experience with validation and qualification of equipment, systems, and manufacturing processes.
• Experience with product release, batch records/DHR review, and quality disposition.
• Strong analytical, problem-solving, and continuous improvement skills.
• Strong written and verbal communication skills.
• Ability to work effectively in a complex, cross-functional environment.
• Self-directed, proactive, and comfortable taking ownership of quality and compliance issues.
• Strong process and data-oriented mindset.

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions. Visit https://dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.