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