Cycle Engineering; LCE Quality Engineer medical devices exp

Life Cycle Engineering (LCE) Quality Engineer With Medical Devices Exp

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