Job Title: Quality Engineer
Job Description
We are seeking a dedicated Quality Engineer to develop, implement, and maintain quality systems in compliance with ISO, FDA 21 CFR Part 820, and EU MDR requirements. This role involves supporting design control activities, including risk management, verification/validation, and design transfer. You will conduct root cause analysis and corrective/preventive actions while collaborating with cross-functional teams to ensure quality throughout the product lifecycle.
Responsibilities
- Develop, implement, and maintain quality systems in accordance with ISO, FDA 21 CFR Part 820, and EU MDR requirements.
- Support design control activities, including risk management (DFMEA, FMEA, PFMEA, Usability Engineering), verification/validation, and design transfer.
- Conduct root cause analysis and corrective/preventive actions (CAPA).
- Collaborate with cross-functional teams (R&D, Regulatory Affairs, Manufacturing, Supply Chain) to ensure quality throughout the product lifecycle.
Essential Skills
- Bachelor's degree in engineering, Life Sciences, or a related field.
- 3–5 years of experience in quality engineering within medical devices or other regulated industries.
- Strong knowledge of ISO, FDA QSR, EU MDR, and risk management standards.
- Familiarity with validation processes (IQ/OQ/PQ) and statistical techniques.
Additional Skills & Qualifications
- Experience with CAPA, nonconformance handling, and root cause analysis tools (e.g., FMEA, 5-Why, Fishbone).
- Proficiency in DFMEA.
Work Environment
The position requires collaboration with various departments including R&D, Regulatory Affairs, Manufacturing, and Supply Chain. The role is critical in ensuring the quality of products throughout their lifecycle.
Work Experience
3-5 years
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.
