LCE Quality Engineer

Must Have Technical/Functional Skill

• 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)

• Hands-on experience in Complaint Handling and Post Market Surveillance (PMS) activities
• 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
• Ability to adapt to evolving data requirements across multiple systems and applications
• Proficient in statistical tools and techniques, including Design of Experiments (DOE)
• Capable of performing advanced descriptive and non parametric statistical analyses
• Skilled in translating real world stressors into executable test strategies to predict field reliability
• Experienced in leveraging advanced statistical methods for reliability prediction and data driven decision making Roles & Responsibilities
• 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
• Drive complaint handling, post market surveillance, risk management, NC, and CAPA activities
• Support audits and regulatory inspections, ensuring timely closure of actions
• Perform and review risk assessments (FMEA, ISO 14971)
• Manage quality deliverables for multiple projects, ensuring timelines and quality goals are met Salary Range $ 80,000-$100,000 Per 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 & Certification & amp; Training Reimbursement.

Time Off:

Vacation, Time Off, Sick Leave & Holidays.

Legal & Financial Assistance:

Legal Assistance, 401K Plan, Pe rformance Bonus, College Fund, Student Loan Refinancing. #LI-SP1