Quality Engineer

Role Overview
We are seeking a detail-oriented and motivated Quality Engineer to support post-market and sustaining quality activities within a highly regulated medical device manufacturing environment. This role plays a critical part in ensuring product quality, regulatory compliance, and continuous improvement of existing medical devices. The selected candidate will work closely with cross-functional teams to investigate product complaints, support corrective and preventive actions (CAPA), maintain risk documentation, and contribute to ongoing product and process improvements. This is an excellent opportunity for a quality professional with 2 3 years of experience to grow within a fast-paced, quality-driven organization focused on delivering life-saving medical technologies.

Pay - $40/hr - $42/hr

Key Responsibilities
Support quality assurance activities in accordance with FDA Quality System Regulation (QSR), ISO 13485, and other applicable regulatory standards
Investigate product complaints and perform failure analysis on returned medical devices
Execute and support Corrective and Preventive Actions (CAPA), including root cause analysis and documentation
Develop and maintain incoming inspection processes and support in-process and final product quality activities
Manage non-conforming materials and participate in Material Review Board (MRB) activities
Maintain and update product risk documentation and support risk review processes
Support post-market product updates and sustaining quality engineering initiatives
Collaborate with cross-functional teams including manufacturing, engineering, suppliers, and quality teams to ensure consistent product quality
Assist with internal audits, quality system improvements, and quality metrics tracking
Contribute to continuous improvement initiatives that enhance product quality and process efficiency

Required Qualifications
Bachelor s degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline)
2 3 years of Quality Engineering experience in a regulated industry
Experience working in Medical Devices, Pharmaceuticals, Electronics Manufacturing, Aerospace, or a similar highly regulated environment
Hands-on experience with CAPA (Corrective and Preventive Actions)
Experience performing complaint investigations and root cause analysis
Exposure to risk assessment, risk documentation, or risk review processes
Experience with inspection processes, non-conforming material, or quality documentation
Strong analytical, problem-solving, and documentation skills
Ability to work effectively in a fast-paced, highly regulated manufacturing environment

Preferred Qualifications
Experience in Medical Device Manufacturing
Familiarity with FDA Quality System Regulation (QSR) and ISO 13485
Experience supporting post-market or sustaining quality engineering activities
Experience participating in MRB (Material Review Board) processes
Exposure to structured problem-solving methodologies such as DMAIC
Strong organizational and time-management skills with the ability to manage multiple priorities

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.