Quality Engineer

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 management
• Change 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) management
• Manages the Nonconforming Materials program.
• Manages the QMS Training program.
• Lead product recalls / field actions, where necessary
• Audits of both internal and supplier
• Audits 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 Analyses
• Assist with creation and maintenance of Project Plans
• Assist with creation and maintenance of Manufacturing Flow Charts, Medical Device Files, Labeling.
• Other duties as assigned

KNOWLEDGE / EDUCATION :

• Bachelor's degree in Engineering
• Strong technical writing / reading skills
• FDA medical device regulations, preferred
• European Medical Device Regulation and of applicable guidance documents, preferred.
• Certified Quality Auditor, preferred
• Supplier Quality Management, preferred
• Product development process, design control, and Quality Systems, preferred

JOB EXPERIENCE :

• Demonstrated success in Medical Device Quality Engineering
• Knowledge of Quality regulations
• Statistical analysis and problem-solving ability

SKILLS / COMPETENCIES :

• Fluent in English
• Self-motivated
• Attention to detail
• Ability to work under minimal supervision
• Ability to work both independently and in a team
• Computer skills; MS Word, Excel, PowerPoint, Adobe Acrobat
• Ability to write clear, concise, and well thought out technical documents
• Knowledge of statistical analysis and problem-solving ability
• Proficient in timely review of technical data
• Ability to manage moderately complex problems / projects by exercising independent decision making and analytical thinking skills
• Must be able to work in a timeline-driven environment

JOB TYPE : Full-time, On-site