Sr Quality Engineer

Job Title:

Sr Quality Engineer

Job Description

This role is responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS). The position supports the global development, implementation, and continuous improvement of the local QMS in compliance with medical device regulations and standards, including FDA 21 CFR Part 820, IEC, and EU MDR.

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 and execute updates to local procedures to meet applicable requirements.

+ Assist in the harmonization of QMS systems.

+ Conduct gap assessments to global requirements.

+ Draft updates and coordinate with key stakeholders like sterilization and cleaning teams.

Essential Skills

+ Quality engineering experience.

+ Proficiency in CAPA, Quality Management System, ISO standards, and medical device experience.

+ Bachelor's degree in engineering.

+

Experience with QMS and FDA 21 CFR Part 820.

+ 4+ years of relevant experience.

+ Skilled in developing and implementing procedures for various QMS elements including purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions.

Additional

Skills & Qualifications

+ Knowledge of software as a medical device (SaMD) is a plus.

+ Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, EU MDR.

+ Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ).

+ CQE or equivalent certification preferred.

Work Environment

This role operates in a hybrid model with flexible start and end times. The team supports an R&D facility with no manufacturing involved. Approximately 90% of the team consists of engineers focusing on development, while quality and regulatory professionals make up the remaining 10%.

Job Type & Location

This is a Contract position based out of Austin, TX.

Pay and Benefits

The pay range for this position is $40.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a hybrid position in Austin,TX.

Final date to receive applications

This position is anticipated to close on Mar 13, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom (%20actalentaccom)  for other accommodation options.