Cycle Engineering; LCE Quality Engineer medical devices exp

Position: Life Cycle Engineering (LCE) Quality Engineer with medical devices exp
Role:
Life Cycle Engineering (LCE) Quality Engineer with medical devices exp

Location:

Blue Ash, OH
Contract

Job Description

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