Sr Quality Engineer

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.

• 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.

• 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.

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.

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)

This is a hybrid position in Austin,TX.

This position is anticipated to close on Apr 28, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.