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

**Location**

Cincinnati, OH

**Job Function**

TECHNOLOGY

**Role**

Engineer

**Job Id**

408945

**Desired Skills**

Design

**Salary Range**

$80,000-$100,000 a year

Desired Candidate Profile

**Qualifications** : BACHELOR OF COMPUTER SCIENCE