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TC
Tata Consultancy Services Limited
Senior Quality Engineer
Career Insights for Director of Quality Assurance
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What they do
A Director of Quality Assurance oversees and directs the overall operations of quality assurance within a company to ensure continuous improvement and compliance.
$169,784 / year median in California
-1% projected decline
Job Description
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 (NCs) 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