Quality Systems Engineer III

Iconma

Austin, TX
3 days ago

$46.40–$49.75 Per Hour

Highlights

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). Requirements: Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.

Numbers & Facts

Location	Austin, TX
Industry	Management Consulting Services
Salary	$46.40–$49.75 Per Hour
Company Size	2,000 to 2,499 employees
Year Founded	2000
Website	https://www.iconma.com/

Description

Our client, a Medical Devices / Healthcare company, is looking for a Quality Systems Engineer III for their Austin, TX/Hybrid location.

Responsibilities:

Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.
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.

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.

Why Should You Apply?

Health Benefits
Referral Program
Excellent growth and advancement opportunities

Benefits

401K, Employee Referral Program, Life Insurance

About Company

ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.

Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
Founded in 2000
2000+ Employees

The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.