Sr Quality Engineer

Sr Quality Engineer

Location:

Santa Clara, CA (Day 1 onsite) Duration:
Fulltime Salary Range - $120,000-$140,000 a year

Roles and Responsibilities:

Must Have Technical/Functional

Skills:

• Strong understanding of Medical Device Quality Systems and regulatory compliance requirements
• Working knowledge of ISO 13485:2016/2019 and 21 CFR Part 820 (FDA Quality System Regulation)
• Strong expertise in design transfer activities, including DHF → DMR transition and compliance with FDA 21 CFR 820 & ISO 13485
• Sound knowledge of Medical Device Regulations, including MDD and MDR
• Proven experience in Non Conformance (NC) management, CAPA processes, and internal/external audits
• Expertise in Medical Device Risk Management, with the ability to identify both apparent and less obvious risks
• Practical experience with Application, Process, Design, and System FMEA methodologies
• Proficient in statistical tools and techniques, including Design of Experiments (DOE)
• Capable of performing advanced descriptive and non parametric statistical analyses
• Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making

Roles & Responsibilities:

• Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness.
• Own multiple subassemblies for a surgical robotics platform, ensuring design integrity, quality, and manufacturability.
• Investigate non-conformances (Company) using root cause analysis and drive CAPA within the QMS framework.
• Develop and maintain FMEAs, support risk mitigation, and lead manufacturing issue resolution and qualifications (IQ/OQ/PQ).
• Identify and implement compliant, alternative solutions to engineering and production challenges while driving continuous improvement.
• Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements
• Collaborate with cross functional teams to deliver quality compliant outcomes
• Interpret and apply medical device regulations and standards to projects and processes
• Support audits and regulatory inspections, ensuring timely closure of actions

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.