Senior Quality Engineer

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

Salary Range: $120,000- $140,000 a year

TCS Employee Benefits

Summary:

Discretionary Annual Incentive.

Comprehensive Medical Coverage:
Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans.

Family Support:
Maternal & Parental Leaves.

Insurance Options:
Auto & Home Insurance, Identity Theft Protection.

Convenience & Professional Growth:
Commuter Benefits & Certificatio n & amp;
Training Reimbursement.

Time Off:
Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance:
Legal Assistance, 401K Plan, Performance Bonus, College Fund, Student Loan Refinancing.

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