Senior Quality Engineer

Company : Compunnel Software Group, Inc.

Location : Austin, TX, 78716

Posted Date : 4 November 2025

Job Type : Other

Category : Industrial Engineering

Occupation : Quality Engineer

Job Details

Job Summary:
The Senior Quality Engineer (QE) is responsible for ensuring the ongoing compliance of the Client North Austin Quality Management System. This role focuses on process maintenance, measurement and analysis, continuous improvement, and audit representation. The Senior QE supports onsite operational and inspection processes for orthopedic devices and provides technical leadership in root cause investigations and quality improvement initiatives.

Key Responsibilities:

Lead the development and implementation of quality programs to ensure products and processes meet specifications and regulatory requirements.
Drive continuous improvement initiatives in Quality Controls to minimize recalls and ensure compliance with industry standards.
Lead or participate in CAPA and non-conformance investigations, serving as the site Subject Matter Expert (SME).
Collaborate cross-functionally with Operations, Regulatory, Product Development, Supplier Quality, and PMO to meet quality system requirements for new product launches and process transfers.
Conduct risk-related activities such as Measurement Systems Analysis (MSA), Gage R&R, and Failure Mode and Effects Analysis (FMEA), presenting findings to facilitate decision-making.
Prepare for and represent the site during internal and external audits.
Perform other duties as assigned by the Site Quality Lead.

Required Skills:

Strong working knowledge of FDA and/or ISO regulations.
Ability to interpret and apply technical standards related to Quality Operations.
Proficiency in quality inspection processes, product lifecycle management systems, and ERP systems (SAP preferred).
Excellent analytical, problem-solving, and documentation skills.
Strong leadership and communication abilities to influence cross-functional teams.

Preferred Skills:

Experience with sterile medical devices and clean room operations.
Familiarity with CAPA systems and risk management tools.

Certifications:
ASQ Certified Quality Engineer (preferred but not required).

Education:
Bachelorâ€™s Degree in an Engineering discipline (required).

Experience:
Minimum of 6 years in Quality Engineering, preferably in the medical device industry.