Website:
actalentservices.com
Job details:
Job Title: Quality Engineer
Job Description
This Quality Engineer role focuses on developing, implementing, and maintaining robust quality systems within a regulated environment, with a strong emphasis on ISO standards, FDA Quality System Regulation (QSMR), and risk management. The position supports medical device quality engineering activities, including design control, validation, and continuous improvement, to ensure products meet regulatory requirements and high standards of safety and performance.
Responsibilities
- Develop, implement, and maintain quality systems in alignment with FDA QSMR requirements and applicable ISO standards.
- Support design control activities throughout the product lifecycle, including risk management, verification, validation, and design transfer.
- Conduct thorough root cause analyses for quality issues using tools such as FMEA, 5-Why, and Fishbone diagrams.
- Lead and manage corrective and preventive actions (CAPA) to address nonconformances and prevent recurrence.
- Handle nonconformance events by documenting issues, coordinating investigations, and driving timely resolution.
- Collaborate with cross-functional teams to ensure quality requirements are integrated into product design and manufacturing processes.
- Apply statistical techniques to analyze quality data, monitor process performance, and identify opportunities for improvement.
- Support validation activities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure processes and equipment consistently meet specifications.
- Maintain accurate and compliant quality records and documentation in accordance with regulatory and internal requirements.
- Contribute to continuous improvement initiatives aimed at enhancing product quality, process efficiency, and regulatory compliance.
Essential Skills
- Strong knowledge of ISO standards relevant to quality management and risk management in regulated industries.
- Strong knowledge of FDA Quality System Regulation (QSMR) requirements.
- Experience with corrective and preventive action (CAPA) processes, including planning, execution, and effectiveness verification.
- Experience handling nonconformances, including documentation, investigation, and resolution.
- Proficiency with root cause analysis tools such as FMEA, 5-Why, and Fishbone diagrams.
- Familiarity with validation processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Ability to apply statistical techniques to support quality analysis and decision-making.
- Experience in quality engineering within a medical device or similarly regulated environment.
- Demonstrated ability to support design control activities, including risk management, verification, validation, and design transfer.
- Strong analytical, problem-solving, and documentation skills.
Additional Skills & Qualifications
- Experience working in a medical device quality engineering role.
- Familiarity with risk management standards applicable to medical devices.
- Ability to collaborate effectively with cross-functional teams, including design, manufacturing, and regulatory functions.
- Strong written and verbal communication skills for preparing reports and quality documentation.
- Detail-oriented approach with a focus on compliance and continuous improvement.
Work Environment
The role operates in a regulated medical device environment that emphasizes adherence to ISO standards and FDA QSMR requirements. You will work closely with cross-functional teams involved in design, manufacturing, validation, and quality assurance, using structured quality tools such as FMEA, 5-Why, Fishbone diagrams, and statistical methods. The position involves significant documentation, analysis, and participation in design control and validation activities, with a strong focus on maintaining compliant quality systems and supporting ongoing process improvements.
Experience: 3-8 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.
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