POSITION PURPOSE: The purpose of this position is to develop, implement, and maintain Quality Management Systems (QMS) and compliance with established standards and agency guidelines like FDA 21 CFR Part 820, 2017/745, and ISO 13485:2016.
This role involves working closely with cross-functional teams to drive continuous improvements in product quality.
SUMMARY OF RESPONSIBILITIES: The Quality Engineer I position will be responsible for day-to-day administration and support of various aspects of the Quality Management System (QMS).
The Quality Engineer I will help develop and maintain the document control system; post market surveillance system; CAPA system; NCMR system; supplier maintenance programs; and quality engineering policies, processes, procedures, and controls to ensure conformance to applicable regulations and standards.
KEY RESPONSIBILITIES: Document control / quality record managementChange Order (CO) routing and tracking CO status and communicating to staff (weekly, biweekly) and assignment of document numbers and CO numbers.Point of contact for auditors.Post market surveillance activities including complaint handling, investigation, and vigilance reporting to relevant authorities.Corrective Action / Preventative Action (CAPA) and Corrective Action Request (CARs) managementManages the Nonconforming Materials program.Manages the QMS Training program.Lead product recalls/field actions, where necessary Audits of both internal and supplierAudits from suppliers, distributors, and regulatory agencies.Supplier qualification and follow-up including communication of new document revisions to suppliers.Assist with creation and maintenance of Design History Files and various protocol, reports, and other deliverables.Assist with creation and maintenance of Risk Management Files and Gap AnalysesAssist with creation and maintenance of Project PlansAssist with creation and maintenance of Manufacturing Flow Charts, Medical Device Files, Labeling.Other duties as assigned KNOWLEDGE/EDUCATION: Bachelor's degree in EngineeringStrong technical writing/reading skillsFDA medical device regulations, preferredEuropean Medical Device Regulation and of applicable guidance documents, preferred.Certified Quality Auditor, preferredSupplier Quality Management, preferredProduct development process, design control, and Quality Systems, preferred JOB EXPERIENCE: Demonstrated success in Medical Device Quality EngineeringKnowledge of Quality regulationsStatistical analysis and problem-solving ability SKILLS/COMPETENCIES: Fluent in EnglishSelf-motivatedAttention to detailAbility to work under minimal supervisionAbility to work both independently and in a teamComputer skills; MS Word, Excel, PowerPoint, Adobe AcrobatAbility to write clear, concise, and well thought out technical documentsKnowledge of statistical analysis and problem-solving abilityProficient in timely review of technical dataAbility to manage moderately complex problems/projects by exercising independent decision making and analytical thinking skillsMust be able to work in a timeline-driven environment JOB TYPE: Full-time, On-site