Job Title: Quality Engineer
Location: Chennai
Work Hours: 2:00 PM 11:00 PM IST
Industry: Medical Devices
Position Overview
We are seeking a
Quality Engineer to support
our medical device development and manufacturing projects. This role will
Ensure Compliance With Regulatory Requirements, Quality Standards, And Company
procedures, while driving continuous improvement initiatives to enhance product
safety and effectiveness.
Key Responsibilities
- Develop, implement, and maintain quality systems in accordance with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
- Support design control activities, including risk management, 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.
- Perform supplier quality audits and manage supplier qualification processes.
- Review and approve validation protocols, reports, and test methods.
- Ensure compliance with Good Manufacturing Practices (GMP) and applicable standards.
- Support internal and external audits, inspections, and regulatory submissions.
- Drive continuous improvement initiatives in quality processes and systems.
Qualifications
- Bachelor's degree in engineering, Life Sciences, or related field.
- 35 years of experience in quality engineering within medical devices or other regulated industries.
- Strong knowledge of ISO 13485, FDA QSR, EU MDR, and risk management standards (ISO 14971).
- Experience with CAPA, nonconformance handling, and root cause analysis tools (e.g., FMEA, 5-Why, Fishbone).
- Familiarity with validation processes (IQ/OQ/PQ) and statistical techniques.
- Excellent communication, documentation, and problem-solving skills.
- Ability to work independently and in cross-functional teams.
Preferred Skills
- Experience with software validation and electronic quality management systems (eQMS).
- Knowledge of Six Sigma or Lean methodologies.
- Prior involvement in new product development projects.
- Audit certification (e.g., ISO 13485 Lead Auditor) is a plus.
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 APACwith 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.
