LCE Quality Engineer
Job DescriptionMust 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 makingRoles & 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 metSalary Range $ 80,000-$100,000 Per yearTCS Employee Benefits SummaryDiscretionary 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.Qualifications: BACHELOR OF COMPUTER SCIENCE