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