Senior Engineer, Quality Systems
$104,622–$141,240 year
On-siteSan Jose, California, United States
Job Summary
Conduct routine and periodic internal and external audits to ensure QMSR, ISO 13485, and other quality standards are maintained. Review internal audit responses for policy consistency and provide technical support during all audit phases. Manage Document and Change Control processes, including database maintenance, while serving as the CAPA Coordinator and mentor for CAPA Owners. Lead cross-functional meetings to align stakeholders, remove barriers, and drive action closure on quality system projects. Drive process standardization, compliance technology adoption, and continuous improvement initiatives such as Six Sigma Kaizen projects. Provide regular reports to management on quality system topics including Audit status, CAPAs, Deviations, and Change Controls. Develop training curriculum to support established quality systems.
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, Compliance, or related discipline
- Training in medical device QMS requirements, validations (hardware and software), quality planning, audit support, risk management, project leadership, remediation management, and Good Documentation Practices
- Minimum of 5 years of experience in Quality Systems, Quality Engineering, Compliance, Regulatory, Engineering, Operations, or a related field
- Working knowledge of medical device QMS requirements and regulated change implementation
- Experience leading quality plans, QMS remediation, policy implementation, regulatory inspection readiness, process standardization, compliance technology implementation (validations)
- Experience mentoring cross-functional team members on quality concepts and preparing compliance updates to management
- Strong technical writing, risk-based thinking, stakeholder management, executive communication, and project leadership skills
- Ability to coach and influence cross-functional teams without direct authority
- Ability to translate regulatory and procedural requirements into practical implementation plans
- In office work environment
- Frequent cross-functional engagement across sites and process ownership teams
- Work may include time-sensitive deliverables, audit readiness support, inspection response, remediation tracking, and leadership reporting
- Requires the ability to manage multiple priorities and support business needs across time zones
Desired Qualifications
- Certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma, or PMP
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.