Job Information
ICONMA, LLC Quality Systems Engineer III in United States
Our Client, a Medical Devices/Healthcare company, is looking for a Quality Systems Engineer III for their Austin, TX/Hybrid location. Responsibilities:
Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.
Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards.
Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements.
This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.
Supporting R&D
90% of the team are engineers
Device already cleared on the market (not commercialized)
Working on a new one
Wanting to submit by EOY
Small team & new
2 engineers will be heavily involved in harmonizing with Zimmer
Be ISO certified
Reporting to Feryal
Working on assisting with QMS harmonization
Helping with draft updates
Coordinating with stakeholders (Zimmer and Monogram)
Collaborating with cross functional teams
Gap analysis for remediation
Requirements:
Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).
Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory).
Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ).
Must have previous Medical Device Experience
Preferred experience with SaMD (Software as a medical device) and class II medical devices.
High school diploma or equivalent required.
Bachelor’s degree in Engineering preferred.
Technical, engineering, and/or scientific background is strongly preferred.
Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required
CQE or equivalent certification preferred.
Must be familiar with Microsoft Office Suite.
Experience in medical device
Experienced with QMS systems & global regulatory
Experience in 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971
Building a QMS or owning and managing it
Looking for more senior level
More than 5 years experience
Why Should You Apply?
Health Benefits
Referral Program
Excellent growth and advancement opportunities
ICONMA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to any status protected by applicable law.