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